Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study sought to verify that the in vitro quality (functional assays) of platelets collected on the Trima Accel system, Version 6.4, diluted in InterSol Solution, and stored for 1, 5, and 7 days meet FDA requirements.
Platelets suspended in platelet additive solutions (PAS) have been collected and transfused in Europe for over 20 years. These PAS solutions outside of the United States (US) are not tied to an apheresis device; however in the US, PAS solutions have traditionally been linked to a corresponding apheresis device.
Currently in the US, there are two solutions approved by the Food and Drug Administration (FDA) as a PAS for the replacement of 65% plasma in platelet components. Isoplate Solution is approved for use with the Trima Accel® Automated Blood Collection System (Trima Accel System) and InterSol Solution is approved for use with the Amicus Separator System.
This study is designed to provide blood centers with the option to use either Isoplate or InterSol when collecting platelets for use with PAS. Terumo BCT is pursuing approval for InterSol Solution in combination with the Trima Accel System.
This is a randomized, paired, prospective, open-label, multi-center study. Up to 120 healthy adult subjects will be enrolled in this study to ensure 60 paired evaluable data points across two Investigational Sites. Evaluable is defined as two completed platelet products with 100mL plasma that do not meet any of the protocol analysis exclusion criteria.
The additional platelet donors account for screen failures, incomplete procedures, and protocol exclusions.
Two units of platelets will be collected from each subject: one Test unit collected as a hyperconcentrated platelet product with 100 mL of concurrent plasma and one Control unit of platelets in plasma collected according to standard procedure. The Test unit will be suspended in 65% Intersol/35% plasma immediately after collection; the Control unit will be maintained in 100% plasma.
Eligible donors who have signed an informed consent will be enrolled. Randomization will occur in a ratio of 1:1 to one of the following Treatment Arms:
Arm A: Collection of one Test unit followed by collection of one Control unit Arm B: Collection of one Control unit followed by collection of one Test unit
The standard apheresis platelet units collected in the Control arm will mirror the hyperconcentrated platelet units in the Test arm in terms of yield and final concentration.
SUBJECT PROCEDURES
Screening can be performed within 30 days of the apheresis procedure or combined with the first Apheresis Visit.
The following evaluations will be performed:
Apheresis Visit
The following procedures will be performed at both the first and second Apheresis Visits:
Subject will return to the Site in 6 to 8 days following the first apheresis collection for the second apheresis collection. This will conclude the subject's participation.
Apheresis procedures will be run according to the instructions and precautions described in the commercially available Trima Accel Operator's Manual for use with Version 6.4.
The Investigator or designee will perform the venipuncture, monitor the subject during the collection, assess and provide any interventions for adverse effects, remove the needle, dress the puncture site and monitor subject through recovery.
The following will be documented:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelets Stored in Plasma | Active Comparator | Platelets stored in Plasma |
|
| Test Platelets Stored in InterSol | Experimental | Platelets stored in InterSol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelets stored in InterSol | Device | A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other. |
| Measure | Description | Time Frame |
|---|---|---|
| pH of Platelets at Day 5 | The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products. | Day 5 |
| pH of Platelets at Day 7 | The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products. | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Platelets Activated as Measured by P-selectin | Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality. | Day 5 |
| Percent of Extent of Shape Change |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jose Cancelas-Perez, MD, PhD | Hoxworth Blood Center | Principal Investigator |
| Mehraboon S Irani, MD | Clood Center of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoxworth Blood Center | Cincinnati | Ohio | 45267 | United States | ||
| Blood Center of Wisconsin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22882530 | Background | Dumont LJ, Cancelas JA, Graminske S, Friedman KD, Vassallo RR, Whitley PH, Rugg N, Dumont DF, Herschel L, Siegal AH, Szczepiorkowski ZM, Fender L, Razatos A. In vitro and in vivo quality of leukoreduced apheresis platelets stored in a new platelet additive solution. Transfusion. 2013 May;53(5):972-80. doi: 10.1111/j.1537-2995.2012.03841.x. Epub 2012 Aug 6. | |
| 15938735 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
87 volunteers signed consent and were enrolled in the study, but 2 were screen fails and therefore did not participate in the study
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | InterSol First, Then Plasma | Platelets collected in InterSol, then platelets collected in plasma |
| FG001 | Plasma First, Then InterSol | Platelets collected in plasma, then platelets collected in InterSol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Platelet Donation (Day 0) |
| |||||||||||||
| Second Platelet Donation (Day 6-8) |
|
The Safety Population includes all participants enrolled in this study who underwent any study related apheresis procedure.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | InterSol First, Then Plasma | Platelets collected in InterSol, then platelets collected in plasma |
| BG001 | Plasma First, Then InterSol | Platelets collected in plasma, then platelets collected in InterSol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | pH of Platelets at Day 5 | The primary endpoint for this study is pH of platelets stored in InterSol at Day 5. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | pH | Day 5 |
|
Treatment emergent adverse events were reported for any participant that underwent any study related apheresis procedure. Only adverse events that occured during the apheresis procedure and until discharge were reported.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Platelets Collected and Stored in InterSol | Platelets stored in InterSol Platelets stored in InterSol: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site extravasation | General disorders | MedDRA; Version 19.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Pidcoke, MD, PhD | Terumo BCT | (303) 231-4805 | Heather.Pidcoke@terumobct.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Platelets stored in Plasma | Device | A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other. |
|
Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality.
| Day 5 |
| Percent of Platelets Exhibiting Hypotonic Shock Response | Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality. | Day 5 |
| Platelet Morphology | 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 values represent healthier platelets. | Day 5 |
| Percent of Platelets Activated as Measured by P-selectin | Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality. | Day 7 |
| Percent of Extent of Shape Change | Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality. | Day 7 |
| Percent of Platelets Exhibiting Hypotonic Shock Response | Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality. | Day 7 |
| Platelet Morphology | 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 values represent healthier platelets. | Day 7 |
| Milwaukee |
| Wisconsin |
| 53233 |
| United States |
| Ringwald J, Walz S, Zimmermann R, Zingsem J, Strasser E, Weisbach V, Eckstein R. Hyperconcentrated platelets stored in additive solution: aspects on productivity and in vitro quality. Vox Sang. 2005 Jul;89(1):11-8. doi: 10.1111/j.1423-0410.2005.00645.x. |
| 24735171 | Background | Cohn CS, Stubbs J, Schwartz J, Francis R, Goss C, Cushing M, Shaz B, Mair D, Brantigan B, Heaton WA. A comparison of adverse reaction rates for PAS C versus plasma platelet units. Transfusion. 2014 Aug;54(8):1927-34. doi: 10.1111/trf.12597. Epub 2014 Apr 16. |
| 18034788 | Background | Diedrich B, Sandgren P, Jansson B, Gulliksson H, Svensson L, Shanwell A. In vitro and in vivo effects of potassium and magnesium on storage up to 7 days of apheresis platelet concentrates in platelet additive solution. Vox Sang. 2008 Feb;94(2):96-102. doi: 10.1111/j.1423-0410.2007.01002.x. Epub 2007 Nov 22. |
| 11952987 | Background | Gulliksson H, AuBuchon JP, Vesterinen M, Sandgren P, Larsson S, Pickard CA, Herschel I, Roger J, Tracy JE, Langweiler M; Biomedical Excellence for Safer Transfusion Working Party of the International Society of Blood Transfusion. Storage of platelets in additive solutions: a pilot in vitro study of the effects of potassium and magnesium. Vox Sang. 2002 Apr;82(3):131-6. doi: 10.1046/j.1423-0410.2002.drfgv158.x. |
| 9924762 | Background | Dumont LJ, VandenBroeke T, Ault KA. Platelet surface P-selectin measurements in platelet preparations: an international collaborative study. Biomedical Excellence for Safer Transfusion (BEST) Working Party of the International Society of Blood Transfusion (ISBT). Transfus Med Rev. 1999 Jan;13(1):31-42. doi: 10.1016/s0887-7963(99)80086-8. No abstract available. |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | inches |
|
| Weight | Mean | Standard Deviation | lbs |
|
| Total Blood Volume (TBV) | Mean | Standard Deviation | mL |
|
| OG001 | Control Platelets Collected and Stored in Plasma | Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other. |
|
|
|
| Primary | pH of Platelets at Day 7 | The primary endpoint for this study is pH of platelets stored in InterSol at Day 7. The FDA acceptance criteria for pH is 95% of products have pH >6.2 at 22 degrees C with 95% confidence interval. A sample size of 60 subjects was chosen for the study to meet the acceptance criteria with 0 failures out of 60 Test products. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | pH | Day 7 |
|
|
|
|
| Secondary | Percent of Platelets Activated as Measured by P-selectin | Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | Percent of Platelets Activated | Day 5 |
|
|
|
|
| Secondary | Percent of Extent of Shape Change | Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | % extent of shape change | Day 5 |
|
|
|
|
| Secondary | Percent of Platelets Exhibiting Hypotonic Shock Response | Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | % of hypotonic shock response | Day 5 |
|
|
|
|
| Secondary | Platelet Morphology | 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 values represent healthier platelets. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | scores on a scale | Day 5 |
|
|
|
|
| Secondary | Percent of Platelets Activated as Measured by P-selectin | Flow cytometric detection of platelet P-selectin expression (Units: %). Lower value is considered to indicate better platelet quality. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | Percent of Platelets Activated | Day 7 |
|
|
|
|
| Secondary | Percent of Extent of Shape Change | Measures the proportion of platelets that have a discoid morphology (Units: %). Higher value is considered to indicate better platelet quality. Higher value is considered to indicate better platelet quality. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | % of extent of shape change | Day 7 |
|
|
|
|
| Secondary | Percent of Platelets Exhibiting Hypotonic Shock Response | Measures the ability of platelets to recover their volume after being exposed to a hypotonic environment (Units: % Recovery). Higher value is considered to indicate better platelet quality. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | % of hypotonic shock response | Day 7 |
|
|
|
|
| Secondary | Platelet Morphology | 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 values represent healthier platelets. | The Full Analysis Set (FAS) was used to examine the primary and secondary endpoints.The FAS consisted of all products where the corresponding Test and Control values for the primary endpoint did not meet any of the protocol analysis exclusion criteria. | Posted | Mean | Standard Deviation | score on a scale | Day 7 |
|
|
|
|
| 0 |
| 82 |
| 0 |
| 82 |
| 9 |
| 82 |
| EG001 | Control Platelets Collected and Stored in Plasma | Platelets stored in Plasma Platelets stored in Plasma: A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other. | 0 | 77 | 0 | 77 | 2 | 77 |
| Paraesthesia oral | Nervous system disorders | MedDRA; Version 19.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA; Version 19.0 | Non-systematic Assessment |
|
Sponsor retains the right to review and comment on any public disclosure of study results. If no response is received within 30 days,the Principal Investigator may presume that the submission for publication may proceed without delay. If the Sponsor asks to defer publication, Study Site shall not publish, or otherwise disclose to any third party, any of the information contained in the publication or presentation until such time as permission is granted from the Sponsor.
The sample size of 60 was chosen to meet the FDA pH requirements that the lower 95% confidence limit on the proportion of platelet test units with pH> 6.2 will be at least 95%. This will be achieved if zero failures (pH<=6.2) is seen.