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
Prospective, multi-center, randomized, controlled clinical trial to study the safety and effectiveness of a novel plasma collection system software.
Prospective, multi-center, randomized, controlled clinical trial that will be conducted at three source plasma collection centers throughout the United States. The objective of the trial is to study the safety and effectiveness of a novel plasma collection nomogram run on the bi-directionally integrated Haemonetics NexSys PCS® and Haemonetics NexLynk DMS® plasma collection system. Subjects will be randomized into an intervention and control arm. The control arm will donate plasma using the current software. The intervention arm will donate plasma using a novel software that supports a more individualized collection approach.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled. |
|
| Control Group | Active Comparator | Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Updated Plasma Collection Feature | Device | Plasma collection using a novel, patented system that supports a more individualized collection approach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Significant Hypotensive Adverse Events | The incidence rate of at least one significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on IQPP definitions of Signs/Symptoms/Findings. Significant adverse events are defined as such events that fulfill the Signs/Symptoms/Findings of IQPP Donor Adverse Events (DAE) classifications 1.2 through 1.6 per the modified, symptoms-based approach following the plasma center adverse event reporting system. A Model Based Prediction method was used for this outcome. | Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Severe Hypotensive Adverse Events | Incidence rate of severe hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, per donation in donors undergoing plasmapheresis. *Only two severe (1.5) adverse events were observed: one in the experimental group and one in the control group. As the secondary analysis for severe hypotensive adverse events was to be conducted only if there were more than 2 severe hypotensive (vasovagal/hypovolemia) adverse events in any of the two study groups, no formal statistical analysis was performed. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
All subjects meeting any of the exclusion criteria listed below will be permanently excluded from the clinical trial.
Donors must indicate their biological gender.
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan F Leitman, MD | National Institutes of Health (NIH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Octapharma Plasma | Wichita | Kansas | 67214 | United States | ||
| Octapharma Plasma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33760230 | Derived | Hartmann J, Ragusa MJ, Burchardt ER, Manukyan Z, Popovsky MA, Leitman SF. Personalized collection of plasma from healthy donors: A randomized controlled trial of a novel technology-enabled nomogram. Transfusion. 2021 Jun;61(6):1789-1798. doi: 10.1111/trf.16389. Epub 2021 Apr 21. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled. Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach. |
| FG001 | Control Group | Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled. Current Plasma Collection Approach: Plasma collection using the current collection approach. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled. Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Significant Hypotensive Adverse Events | The incidence rate of at least one significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on IQPP definitions of Signs/Symptoms/Findings. Significant adverse events are defined as such events that fulfill the Signs/Symptoms/Findings of IQPP Donor Adverse Events (DAE) classifications 1.2 through 1.6 per the modified, symptoms-based approach following the plasma center adverse event reporting system. A Model Based Prediction method was used for this outcome. | Posted | Number | 95% Confidence Interval | % of significant hypotensive AEs | Up to approximately 3 months (total trial duration during which donors could donate), depending on time of enrollment into the trial. | Donations | Donations |
|
Adverse Events were monitored and collected for all donations of study participants throughout the entire duration of the clinical trial, approximately 3 months.
For the purposes of this clinical trial, all adverse events (AEs) were defined and categorized according to established local guidelines and operating procedures and in accordance with IQPP definitions of Signs/Symptoms/Findings.
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 | Experimental Group | Plasma collection using a modified version (version 1.3.90) of NexSys PCS embedded software installed on current FDA-cleared NexSys PCS device hardware (PCS-300-US), with the new plasma collection feature enabled. Updated Plasma Collection Feature: Plasma collection using a novel, patented system that supports a more individualized collection approach. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IQPP 9.1 Other | Nervous system disorders | Systematic Assessment | A reaction that does not fall into any other IQPP category. In this event, donor reported feeling dizzy during standard screening, prior to any plasmapheresis or study activities. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jan Hartmann, MD, Vice President of Medical Affairs and Clinical Development | Haemonetics Corporation | (781) 348 7396 | Jan.Hartmann@haemonetics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 26, 2020 | Feb 15, 2021 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 19, 2020 | Feb 15, 2021 | Prot_001.pdf |
Not provided
Not provided
Not provided
Two-arm, randomized, controlled trial
Not provided
Not provided
Not provided
| Current Plasma Collection Approach | Device | Plasma collection using the current collection approach. |
|
| Up to approximately 3 months, depending on time of enrollment into the trial. |
| Rate of Significant Hypotensive Adverse Events Relative to Volume | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, relative to the actual plasma volume collected. *The outcome is reported as the expected number of significant hypotensive adverse events per 10,000 L of collected plasma. This outcome was calculated using the total number of significant hypotensive adverse events and the total amount of plasma collected, then normalized to 10,000 L of collected plasma. | Up to approximately 3 months, depending on time of enrollment into the trial. |
| Time From Start of Collection to First Significant Hypotensive Adverse Event | Time from start of plasmapheresis "Begin Draw" to the first significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings. | Up to approximately 3 months, depending on time of enrollment into the trial. |
| Rate of Significant Hypotensive Adverse Events Relative to Bodyweight | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a bodyweight of less than or equal to 130 lbs and those greater than 130 lbs. *Note: Due to the absence of AE in the subgroup of donors with bodyweight of ≤130 lbs, no formal statistical analysis was performed. | Up to approximately 3 months, depending on time of enrollment into the trial. |
| Rate of Significant Hypotensive Adverse Events Relative to BMI | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a body mass index (BMI) of less than or equal to 30 and of those greater than 30. | Up to approximately 3 months, depending on time of enrollment into the trial. |
| Rate of Significant Hypotensive Adverse Events Relative to Donor Status | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their respective status as a first-time donor or repeat donor. | Up to approximately 3 months, depending on time of enrollment into the trial. |
| Rate of Significant Hypotensive Adverse Events Relative to Gender | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their gender. | Up to approximately 3 months, depending on time of enrollment into the trial. |
| Total Volume | Total plasma volume collected per procedure. | Up to approximately 3 months, depending on time of enrollment into the trial. |
| Charlotte |
| North Carolina |
| 28217 |
| United States |
| Octapharma Plasma | Spokane | Washington | 99208 | United States |
| BG001 | Control Group | Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled. Current Plasma Collection Approach: Plasma collection using the current collection approach. |
| BG002 | Total | Total of all reporting groups |
| Donations |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | participants | Participants |
|
|
| BMI | Mean | Standard Deviation | kg/m^2 | Participants |
|
|
| Weight | Mean | Standard Deviation | lbs | Participants |
|
|
| Height | Mean | Standard Deviation | in | Participants |
|
|
| Donor Status | Count of Participants | Participants | Participants |
|
|
| Hematocrit | Mean | Standard Deviation | percentage of red blood cells | Participants |
|
|
| OG001 | Control Group | Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled. Current Plasma Collection Approach: Plasma collection using the current collection approach. |
|
|
| Secondary | Rate of Severe Hypotensive Adverse Events | Incidence rate of severe hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, per donation in donors undergoing plasmapheresis. *Only two severe (1.5) adverse events were observed: one in the experimental group and one in the control group. As the secondary analysis for severe hypotensive adverse events was to be conducted only if there were more than 2 severe hypotensive (vasovagal/hypovolemia) adverse events in any of the two study groups, no formal statistical analysis was performed. | Posted | Number | Severe Hypotensive Adverse Events | Up to approximately 3 months, depending on time of enrollment into the trial. | Donations | Donations |
|
|
|
| Secondary | Rate of Significant Hypotensive Adverse Events Relative to Volume | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, relative to the actual plasma volume collected. *The outcome is reported as the expected number of significant hypotensive adverse events per 10,000 L of collected plasma. This outcome was calculated using the total number of significant hypotensive adverse events and the total amount of plasma collected, then normalized to 10,000 L of collected plasma. | This analysis was performed on the PP (per protocol) population, defined as all donations where the apheresis procedure was successfully completed collecting at least 90% of target plasma volume as well as all donations associated with a significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings. | Posted | Number | No. of AEs per 10,000L of Plasma | Up to approximately 3 months, depending on time of enrollment into the trial. | Donations | Donations |
|
|
|
| Secondary | Time From Start of Collection to First Significant Hypotensive Adverse Event | Time from start of plasmapheresis "Begin Draw" to the first significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings. | Posted | Mean | Standard Deviation | minutes | Up to approximately 3 months, depending on time of enrollment into the trial. | Donations | Donations |
|
|
|
| Secondary | Rate of Significant Hypotensive Adverse Events Relative to Bodyweight | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a bodyweight of less than or equal to 130 lbs and those greater than 130 lbs. *Note: Due to the absence of AE in the subgroup of donors with bodyweight of ≤130 lbs, no formal statistical analysis was performed. | The total number of Participants Analyzed is more than the total population of donors in the study as some donors moved from one bodyweight group to the other throughout their participation in the study. Therefore, this analysis was done at the donation level, based on the bodyweight of each donor at the time of each donation. The number of donations are therefore also listed. | Posted | Number | 95% Confidence Interval | % of significant hypotensive AEs | Up to approximately 3 months, depending on time of enrollment into the trial. | Donations | Donations |
|
|
|
| Secondary | Rate of Significant Hypotensive Adverse Events Relative to BMI | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors with a body mass index (BMI) of less than or equal to 30 and of those greater than 30. | The total number of Participants Analyzed is more than the total population of donors in the study as some donors moved from one BMI group to the other throughout their participation in the study. Therefore, this analysis was done at the donation level, based on the BMI of each donor at the time of each donation. The number of donations are therefore also listed. | Posted | Number | 95% Confidence Interval | % of significant hypotensive AEs | Up to approximately 3 months, depending on time of enrollment into the trial. | Donations | Donations |
|
|
|
| Secondary | Rate of Significant Hypotensive Adverse Events Relative to Donor Status | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their respective status as a first-time donor or repeat donor. | Posted | Number | 95% Confidence Interval | % of significant hypotensive AEs | Up to approximately 3 months, depending on time of enrollment into the trial. | Donations | Donations |
|
|
|
| Secondary | Rate of Significant Hypotensive Adverse Events Relative to Gender | Incidence rate of significant hypotensive (vasovagal/hypovolemia) adverse events according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings, in the subgroups of donors defined by their gender. | Posted | Number | 95% Confidence Interval | % of significant hypotensive AEs | Up to approximately 3 months, depending on time of enrollment into the trial. | Donations | Donations |
|
|
|
| Secondary | Total Volume | Total plasma volume collected per procedure. | This analysis was performed on the PP (per protocol) population, defined as all donations where the apheresis procedure was successfully completed collecting at least 90% of target plasma volume as well as all donations associated with a significant hypotensive (vasovagal/hypovolemia) adverse event according to the plasma center adverse event reporting system, based on the IQPP definitions of Signs/Symptoms/Findings. | Posted | Mean | 95% Confidence Interval | mL | Up to approximately 3 months, depending on time of enrollment into the trial. | Donations | Donations |
|
|
|
| 0 |
| 1,717 |
| 0 |
| 1,717 |
| 76 |
| 1,717 |
| EG001 | Control Group | Plasma collection using a modified version (version 1.3.90) of NexSys® PCS embedded software installed on current FDA-cleared NexSy PCS device hardware (PCS-300-US), with the new plasma collection feature disabled. Current Plasma Collection Approach: Plasma collection using the current collection approach. | 0 | 1,726 | 0 | 1,726 | 66 | 1,726 |
|
| IQPP 8.1 Hyperventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | May include Anxiousness / Anxiety; Carpopedal Spasms; Chest Tightness; Dry Mouth; Paresthesia (Perioral -Tingling/Numbness); Paresthesia (Peripheral - Hands/Feet); Respiration, Rapid; Restlessness; Shaking; Shortness of Breath; or Tetany. |
|
| IQPP 7.1 Allergic: Local | Immune system disorders | Systematic Assessment | May include Itching; Rash/Hives; or Redness. |
|
| IQPP 4.2 Citrate Reaction: Moderate | Injury, poisoning and procedural complications | Systematic Assessment | May include Carpopedal Spasms; Chest Pressure; Cold Extremities; Chills; Muscle Tightness/Cramping; Nausea; Pallor, Pale Skin or Lips; Shortness of Breath; Sneezing/Nasal Congestion; Tetany (Transient); Tremors; Twitching; or Vomiting. |
|
| IQPP 4.1 Citrate Reaction: Minor | Injury, poisoning and procedural complications | Systematic Assessment | May include Metallic Taste; Paresthesia (Perioral - Lips (Tingling/Numbness); or Paresthesia (Peripheral - Hands/Feet Tingling/Numbness). |
|
| IQPP 3.3 Local Injury Related to Phlebotomy: Hematoma/Bruise (complicated) | Injury, poisoning and procedural complications | Systematic Assessment | May include Paresthesias, Numbness/Tingling of Fingers, Hand, or Arm; Pressure; Redness; Restricted Movement; Shooting Pain Down Arm; Significant Pain; Skin Discoloration; Swelling; Tenderness; Warmth; or Weakness of Arm. |
|
| IQPP 3.2 Local Injury Related to Phlebotomy: Hematoma/Bruise (uncomplicated) | Injury, poisoning and procedural complications | Systematic Assessment | May include Mild Pain; No Restriction of Movement; Skin Discoloration; or Swelling. |
|
| 3.1 Local Injury Related to Phlebotomy: Nerve Irritation | Injury, poisoning and procedural complications | Systematic Assessment | May include Immediate Intense Pain at Site; Paresthesias, Numbness/Tingling of Fingers, Hand, or Arm; Shooting Pain Down Arm; or Weakness of Arm. |
|
| IQPP 1.5 Hypotensive (Vasovagal/Hypovolemia); Severe (With or Without LOC) | Vascular disorders | Systematic Assessment | This reaction may or may not include LOC and may include Chest Pain, Convulsions/Seizures, Loss of Bladder/Bowel |
|
| IQPP 1.4 Hypotensive (Vasovagal/Hypovolemia): LOC (prolonged) | Vascular disorders | Systematic Assessment | In this reaction, LOC lasts approximately sixty seconds or longer. |
|
| IQPP 1.3 Hypotensive: LOC (brief) | Vascular disorders | Systematic Assessment | In this reaction, LOC lasts approximately less than sixty seconds. |
|
| IQPP 1.2 Hypotensive: Prefaint, No LOC (Moderate): | Vascular disorders | Systematic Assessment | This reaction includes vomiting. |
|
| IQPP 1.1 Hypotensive: Prefaint, No LOC (Minor) | Vascular disorders | Systematic Assessment | May include one or more of minor symptoms, e.g., abdominal cramps, auditory disturbance, chills or shivering, clammy, cold extremities, dizziness, nausea, sweating, weakness. |
|
Site and Investigator shall not publish, disclose, present or use for instruction any Results arising out of its conduct of the Study at the Site without the express prior written consent of Sponsor, except to the extent required by applicable law. Sponsor shall have final review and approval rights for any authorized publication by Investigator, including but not limited to publication strategy, publication decisions, publication content and authorship decisions.
| Title | Measurements |
|---|---|
|
| Donations |
|
| Donations |
|
| Donations |
|
| Donations |
|