In Vivo Study to Assess the Recovery and Survival of Radi... | NCT04022889

Label	Type	Description	Intervention Names
Stage 1	Experimental	The study will be performed in two stages. Stage 1 is a randomized, 2-period crossover design. Test platelets stored for 7 days will be radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods will be compared with each other and against the fresh platelet Control. With agreement from the FDA (BQ200481, July 8, 2020), completion of Stage 1 is not required.	Device: INTERCEPT Treated Platelets
Stage 2	Experimental	Stage 2 is a single arm design. Test platelets from 24 healthy subjects, stored for 7 days, will be prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets will be compared against the fresh platelet Control. Stage 1 subjects with evaluable Variant 1 method data will contribute to the requirement of the 24 subjects for Stage 2.	Device: INTERCEPT Treated Platelets

Name	Type	Description	Arm Group Labels	Other Names
INTERCEPT Treated Platelets	Device	Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) will be simultaneously administered intravenously into the subject.

Measure	Description	Time Frame
Post Infusion Recovery of Test Platelets at End of Storage (Day 7)	Recovery of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is >66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66*Control) in survival is greater than or equal to zero.	11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets
Post Infusion Survival of Test Platelets at End of Storage	Survival of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is >58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 * Control) in survival is greater than or equal to zero.	11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets

Measure	Description	Time Frame
Platelet Dose in Test Component	Percentage of Test components with ≥ 3.0×10^11 platelets	At the end of INTERCEPT treatment on Day 1 or Day 2
Platelet Yield Retention	Percentage of Test components with ≥80% platelet yield retention

Measure	Description	Time Frame
Assessment of the Stored Test (INTERCEPT) Platelet Components: Component Volume	Component volume was summarized descriptively for Stage 1 and Stage 2 Test components	At the end of storage on Day 7
Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Count

Facility	Status	City	State	ZIP	Country	Contacts
Hoxworth Blood Center		Cincinnati	Ohio	45221	United States
Bloodworks Northwest Research Institute

ID	Title	Description
FG000	Stage 1- BEST - Variant 1	Stage 1 is a randomized, 2-period crossover design. Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. A subject was considered "enrolled" upon signing the informed consent form. The Safety Analysis Set comprised all subjects who initiated an apheresis collection.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 16, 2020	Apr 11, 2022

Primary

Post Infusion Recovery of Test Platelets at End of Storage (Day 7)

Recovery of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is >66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66*Control) in survival is greater than or equal to zero.

The Evaluable Analysis Set (EAS) comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation. EAS was the primary analysis population for the efficacy evaluation.

Posted

Mean

Standard Deviation

percentage of infused platelets

11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm - TEST	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
OG001	Stage 1 - Variant 1 Arm - CONTROL	An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
OG002	Stage 1 - BEST Arm- TEST	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled based on the BEST method.
OG003	Stage 1 - BEST Arm - CONTROL	An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.
OG004	Stage 2 - TEST	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.
OG005	Stage 2 - CONTROL	An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to Stage 2.

Units	Counts
Participants	OG00012 OG00112 OG00212 OG003

Title

Denominators

Categories

Title	Measurements
	OG00039.5± 10.3 OG00157.8± 11.6 OG00239.1± 10.6 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Mean Difference (Final Values)	1.4	Standard Deviation	7.7	2-Sided	95	-3.5	6.2			The mean treatment difference is defined as Test recovery - (0.66 × Control recovery).		Non-Inferiority	The null hypothesis of inferiority was to be rejected in favor of the alternative hypothesis of non-inferiority at the two-sided 0.05 significance level if the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.66 × Control) was greater than or equal to zero.

Primary

Post Infusion Survival of Test Platelets at End of Storage

Survival of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is >58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 * Control) in survival is greater than or equal to zero.

The Evaluable Analysis Set (EAS) comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation. EAS was the primary analysis population for the efficacy evaluation.

Posted

Mean

Standard Deviation

hours

11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm- TEST	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days were radiolabeled with Variant 1 method.
OG001	Stage 1 - Variant 1 Arm - CONTROL	An aliquot of autologous, freshly prepared platelets derived from a whole blood sample, collected on the day of infusion and radiolabeled based on the BEST method.

Secondary

Platelet Dose in Test Component

Percentage of Test components with ≥ 3.0×10^11 platelets

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Count of Participants

Participants

At the end of INTERCEPT treatment on Day 1 or Day 2

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data will contribute to Stage 2.

Secondary

Platelet Yield Retention

Percentage of Test components with ≥80% platelet yield retention

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Count of Participants

Participants

At the end of INTERCEPT treatment on Day 1 or Day 2

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data will contribute to Stage 2.

Secondary

pH 22°C

Percentage of Test components with pH 22°C ≥ 6.2

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Count of Participants

Participants

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method. Twelve Stage 1 subjects with evaluable Variant 1 method data will contribute to Stage 2.

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Component Volume

Component volume was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mL

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Count

Platelet count was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

×10^3 platelets/µL

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Dose

Platelet dose was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

×10^11 platelets

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: MPV

MPV was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

fL

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: pO2

pO2 was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mm Hg

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pO2

pO2 normalized for platelet count was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

µmol/hrs/10^12 platelets

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: pCO2

pCO2 was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mm Hg

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pCO2

pCO2 was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

µmol/hrs/10^12 platelets

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: HCO3

HCO3 was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mmol/L

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized HCO3

HCO3 was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mmol/10^12 platelets

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Glucose

Supernatant glucose was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mmol/L

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Glucose

Supernatant glucose was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mmol/10^12 platelets

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate

Supernatant lactate was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mmol/L

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Lactate

Supernatant lactate was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mmol/10^12 platelets

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Total ATP

Total ATP was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

µmol/dL

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Total ATP

Total ATP was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

nmol/10^8 platelets

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Morphology

The morphology score quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher morphology scores represent healthier platelets. Morphology was summarized descriptively for Stage 1 and Stage 2 Test components.

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

score on a scale

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Extent of Shape Change

The Extent of Shape Change is a measurement of agonist-induced, disc-to-sphere shape change of platelets using an aggregometer. It is a quantitative assessment of the proportion of platelets that have discoid morphology in a platelet suspension. Higher values indicate better platelet quality. An aggregometer instrument is to make this measurement. Extent of Shape Change was summarized descriptively for Stage 1 and Stage 2 Test components.

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

percentage of extent of shape change

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Hypotonic Shock Response

Hypotonic Shock Response is used as an index of platelet integrity and metabolic homeostasis. An aggregometer instrument was used to measure the ability of platelets to recover their volume after being exposed to a hypotonic environment. Higher values of Hypotonic Shock Response indicate better platelet quality. Hypotonic Shock Response was summarized descriptively for Stage 1 and Stage 2 Test components.

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

percentage of hypotonic shock response

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate Dehydrogenase (LDH) Activity

Supernatant levels of LDH in PCs represent normal plasma LDH plus LDH released by platelets through cell leakage and injury. Supernatant LDH activity was summarized descriptively for Stage 1 and Stage 2 Test components.

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

U/L

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant LDH

Supernatant LDH activity was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

U/10^12 platelets

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Total LDH Activity

Total LDH activity was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

U/L

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002	Stage 2

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant LDH Proportion of Total LDH

Supernatant LDH Proportion of Total LDH, ratio of LDH supernatant to the total LDH, was summarized descriptively for Stage 1 and Stage 2 Test components

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

percentage of cell free LDH to total LDH

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.
OG002

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: Baseline Adjusted Lysis

For calculation of baseline adjusted lysis the baseline/input supernatant LDH is subtract from the Day 7 supernatant LDH; the lysis is calculated from from the Day 7 adjusted supernatant LDH and Day 7 total LDH values. Baseline Adjusted Lysis was summarized descriptively for Stage 1 and Stage 2 Test components.

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

- % of cell free LDH increased from base

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.

Other Pre-specified

Assessment of the Stored Test (INTERCEPT) Platelet Components: P-selectin (CD62P)

Measurement of P-selectin (CD62P) exposure is often used as an index of platelet activation as it is translocated from the alpha granule to the plasma membrane during platelet secretion. This is a sensitive assay to quantify platelet potential for activation. Higher levels of P-selectin indicate more activation. P-selectin was measured by flow cytometry and was summarized descriptively for Stage 1 and Stage 2 Test components.

Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

percentage of CD62P platelets

At the end of storage on Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with Variant 1 method.
OG001	Stage 1 - BEST Arm	Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) stored for 7 days. Samples from this component were radiolabeled with BEST method.

Other Pre-specified

In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Sample Volume From Component

Stage 1 and Stage 2 sample volume from platelet component was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.

Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

mL

Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following Variant 1 method.
OG001	Stage 1 - BEST Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
OG002

Other Pre-specified

In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Count

Stage 1 and Stage 2 platelet count was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.

Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

×10^3 platelets/µL

Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following Variant 1 method.
OG001	Stage 1 - BEST Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
OG002	Stage 2

Other Pre-specified

In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Yield (Physical Recovery)

In vitro physical platelet recovery is expressed as the percentage of platelets that are remaining after preparation of the Test sample for radiolabeling, prior to addition of the radiolabel, compared to the number of platelets that were present prior to sample preparation. This measurement shows the loss of platelets during the sample preparations and also provides a process control parameter to ensure that the platelet sample used for radiolabeling is representative of the platelet population in the entire platelet component. Stage 1 and Stage 2 Platelet Yield (Physical Recovery) was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.

Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

percentage of physical recovery

Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following Variant 1 method.
OG001

Other Pre-specified

In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With Physical Recovery ≥ 80%

The percentage of Stage 1 and Stage 2 samples with physical recovery ≥ 80% was summarized for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.

Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Count of Participants

Participants

Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following Variant 1 method.
OG001	Stage 1 - BEST Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.

Other Pre-specified

In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: pH 22°C

Stage 1 and Stage 2 pH 22°C was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.

Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

pH unit

Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following Variant 1 method.
OG001	Stage 1 - BEST Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
OG002	Stage 2

Other Pre-specified

In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With pH 22°C ≥ 6.2

The percentage of Stage 1 and Stage 2 samples with pH 22°C ≥ 6.2 was summarized for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.

Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Count of Participants

Participants

Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following Variant 1 method.
OG001	Stage 1 - BEST Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.
OG002

Other Pre-specified

In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Red Blood Cell Total Count

The Red Blood Cell Total Count was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1.

Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

cells

Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following Variant 1 method.
OG001	Stage 1 - BEST Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.

Other Pre-specified

In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: White Blood Cell Total Count

The White Blood Cell Total Count was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1.

Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

cells

Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following Variant 1 method.
OG001	Stage 1 - BEST Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following BEST method.

Other Pre-specified

In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: P-selectin Expression (CD62P)

Measurement of P-selectin (CD62P) exposure is often used as an index of platelet activation as it is translocated from the alpha granule to the plasma membrane during platelet secretion. This is a sensitive assay to quantify platelet potential for activation. Higher levels of P-selectin indicate more activation. Measurement of P-selectin prior to radiolabeling allows assessment of the amount of platelet activation induced by the sample preparation process when compared to the Day 7 P-selectin levels in the platelet component. The P-selectin expression (CD62P) was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1.

Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).

Posted

Mean

Standard Deviation

percentage of CD62P platelets

Day 7

ID	Title	Description
OG000	Stage 1 - Variant 1 Arm	Samples from 7-day old Test platelets (INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets) prior to addition of radiolabel following Variant 1 method.
OG001	Stage 1 - BEST Arm

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Stage 1-Variant 1	The study was performed in two stages. Stage 1 was a randomized, 2-period crossover design. Test platelets stored for 7 days were radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods was compared with each other and against the fresh platelet Control. With agreement from the FDA (BQ200481, July 8, 2020), completion of Stage 1 was not required. INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-24°C with continuous agitation. Samples from the Test component were processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) was simultaneously administered intravenously into the subject.	13	13	8	13
EG001	Stage 1-BEST	The study was performed in two stages. Stage 1 was a randomized, 2-period crossover design. Test platelets stored for 7 days were radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods was compared with each other and against the fresh platelet Control. With agreement from the FDA (BQ200481, July 8, 2020), completion of Stage 1 was not required. INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-24°C with continuous agitation. Samples from the Test component were processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) was simultaneously administered intravenously into the subject.	15	15	11	15
EG002	Stage 2-Variant 1	Stage 2 is a single arm design. Test platelets from 23 healthy subjects, stored for 7 days, were prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets were compared against the fresh platelet Control. Twelve Stage 1 subjects with evaluable Variant 1 method data contributed to the requirement of the 23 subjects for Stage 2. Stage 2 AEs did not include the Variant 1 subjects from Stage 1. INTERCEPT Treated Platelets: Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7 days at 20-24°C with continuous agitation. Samples from the Test component were processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) were simultaneously administered intravenously into the subject.	17	17	10	17

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distention	Gastrointestinal disorders	MedDRA Version 18.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected17 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected17 at risk
Paraesthesia Oral	Gastrointestinal disorders	MedDRA Version 18.0	Systematic Assessment	EG0002 affected13 at risk EG0011 affected15 at risk EG0028 affected17 at risk
Fatigue	General disorders	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected17 at risk
Injection site extravasation	General disorders	MedDRA Version 18.0	Systematic Assessment	EG0001 affected13 at risk EG0013 affected15 at risk EG0022 affected17 at risk
Injection site haematoma	General disorders	MedDRA Version 18.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected17 at risk
Injection site pain	General disorders	MedDRA Version 18.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0021 affected17 at risk
Pyrexia	General disorders	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected17 at risk
Vessel puncture site bruise	General disorders	MedDRA Version 18.0	Systematic Assessment	EG0002 affected13 at risk EG0010 affected15 at risk EG0020 affected17 at risk
Bronchitis	Infections and infestations	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected17 at risk
Kidney Infection	Infections and infestations	MedDRA Version 18.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected17 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected17 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 18.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected17 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA Version 18.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected17 at risk
Arthraigia	Musculoskeletal and connective tissue disorders	MedDRA Version 18.0	Systematic Assessment	EG0001 affected13 at risk EG0010 affected15 at risk EG0020 affected17 at risk
Dizziness	Nervous system disorders	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0021 affected17 at risk
Paraesthesia	Nervous system disorders	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0013 affected15 at risk EG0020 affected17 at risk
Presyncope	Nervous system disorders	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected17 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0012 affected15 at risk EG0020 affected17 at risk
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0020 affected17 at risk
Haematoma	Vascular disorders	MedDRA Version 18.0	Systematic Assessment	EG0000 affected13 at risk EG0011 affected15 at risk EG0023 affected17 at risk

ID	Title	Description
BG000	Stage 1	Stage 1 was comprised of a randomized 2-arm, 2-period crossover design (Period 1 and Period 2). Each subject was randomized to Arm 1 or 2 of the study to determine which methodology was used in Period 1 and Period 2 to prepare and radiolabel the Test platelets. In Arm 1, Test platelets were radiolabeled using the Variant 1 method in Period 1 and the BEST method in Period 2. Test platelets in Arm 2 were radiolabeled using the BEST method in Period 1 and the Variant 1 method in Period 2. Test platelets were derived from apheresis platelet components in 100% plasma, collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets and stored for 7 days. The recovery and survival for Test platelets was compared against the fresh platelet Control. A subject was considered "enrolled" upon signing the informed consent form. Demographics are summarized for the Safety Analysis Set which was comprised all subjects who initiated an apheresis collection for Stage 1.
BG001	Stage 2	Stage 2 was comprised of a single period. Test platelets were derived from apheresis platelet components in 100% plasma, collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets and stored for 7 days. On Day 7 Test platelets were prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets was compared against the fresh platelet Control. A subject was considered "enrolled" upon signing the informed consent form. Safety Analysis Set which comprised all subjects who initiated an apheresis collection; the Safety Analysis Set for Stage 2 comprised 12 Stage 1 subjects with evaluable Variant 1 method data and 17 new Stage 2 subjects. Demographics are summarized for the 17 new Stage 2 subjects.
BG002	Total	Total of all reporting groups