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This is an in vivo 24-hour in-vivo recovery study of leukoreduced red blood cells (RBCs) collected on the Trima Accel System using Non-DEHP disposable sets and stored for 42 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy adult participants | Experimental | Performance criteria will be evaluated in healthy adult participants, who receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 2-6°C. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trima Accel Auto RBC Collection | Device | This is a non-interventional study, observing the in vivo performance of LR-RBC units derived from Trima Accel Auto RBC collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method) | The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria.
| 43 days |
| Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method) | The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria.
| 43 days |
| Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method) | The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria.
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Inclusion Criteria:
Given written informed consent.
Age 18 years or older.
Normal health status as per AABB criteria for healthy donor.
Able to commit to the study schedule.
Meets the inclusion criteria defined by site SOPs for automated blood component collection systems or whole blood donation. These criteria are based on AABB standards and FDA regulations.
a. Note: Participants who are deferred from volunteer community donations due to certain restrictions may participate in the study, as products are not used for allogeneic transfusion; however, sites may or may not implement this depending on their standard procedures.
Participants of childbearing potential (either male or female) must agree to use a medically acceptable method of contraception throughout the study.
Female participants of childbearing potential must agree to take a pregnancy test prior to the apheresis procedure and prior to reinfusion of radiolabeled LR-RBCs.
Participants must agree to report AEs throughout their participation in the study
Exclusion Criteria:
Currently pregnant or nursing females.
Serum ferritin less than12 ng/mL
Has previously completed this study with data included in the EAS.
Participation currently, or within the past 30 days, in another investigational trial that would potentially interfere with the analysis of this investigation (eg, pharmaceutical trial).
As determined by the Investigator:
Treatment with any medication as specified in site deferral list (based on AABB medication deferral list for apheresis donors).
Previously transfused/reinfused with RBCs within the last 120 days.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoxworth Blood Center, University of Cincinnati College of Medicine | Cincinnati | Ohio | 45267 | United States | ||
Privacy concerns
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37 participants signed consent, with 7 (i.e., screen fails) subjects not meeting the study's eligibility criteria.
A donor is considered an "enrolled" participant upon giving informed consent for study participation; this timepoint represents the beginning of a participant's involvement in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Adult Participants | Performance criteria will be evaluated in healthy adult participants, who receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 2-6°C. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Adult Participants | Performance criteria will be evaluated in healthy adult participants, who receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 2-6°C. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Single-label Method) | The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria.
| The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with valid 24-hour recovery endpoint(s) for the single-label (25 evaluable data points) and dual-label (24 evaluable data points) methods without having met any of the protocol analysis exclusion criteria described in the CIP. | Posted | Count of Participants | Participants | 43 days |
During a clinical investigation, all AEs occurring from time of exposure to the investigational non-DEHP disposable until end of study participation were recorded. Adverse event assessments occurred at Day 0, Day 42, and Day 43. There was no long-term follow-up.
Only procedure emergent AEs (PEAEs) were included in the safety evaluation. Collection of PEAEs began at the time of the first exposure to investigational non-DEHP disposable and continued throughout the entire study until study exit or observed related AEs were resolved. Starting with the first baseline procedure, any new event/experience that was not present at baseline, or worsening of an event present at baseline, was considered an AE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Adult Participants | Performance criteria will be evaluated in healthy adult participants, who receive radiolabeled, autologous infusions of LR-RBC components after being stored for 42 days at 2-6°C. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Puncture site bruise | General disorders | MedDRA version 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janet Johnson, RAC / Vice President, Global Regulatory, Clinical Affairs & Labeling | Terumo BCT, Inc. | +1 (720) 668-1021 | Janet.Johnson@terumobct.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2024 | Jan 26, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 26, 2025 | Jan 26, 2026 | SAP_001.pdf |
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| 43 days |
| Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method) | The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria.
| 43 days |
| American Red Cross, Norfolk Clinical Research Lab |
| Norfolk |
| Virginia |
| 23510 |
| United States |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Primary | Number of Participants With Success of RBCs in Vivo Recovery After 42-day Storage (Dual-label Method) | The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria.
| The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with valid 24-hour recovery endpoint(s) for the single-label (25 evaluable data points) and dual-label (24 evaluable data points) methods without having met any of the protocol analysis exclusion criteria described in the CIP. | Posted | Count of Participants | Participants | 43 days |
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| Primary | Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Single-label Method) | The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria.
| The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with valid 24-hour recovery endpoint(s) for the single-label (25 evaluable data points) and dual-label (24 evaluable data points) methods without having met any of the protocol analysis exclusion criteria described in the CIP. | Posted | Mean | Standard Deviation | % 24-hr RBC Recovery | 43 days |
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| Primary | Mean 24-hour, Post-transfusion, in Vivo RBC Recovery Percentage After 42-day Storage (Dual-label Method) | The primary outcome of this study is to demonstrate that LR-RBCs collected on the Trima Accel system using non-DEHP disposable tubing sets with AS-3 meet the FDA criteria for 24-hour recovery after 42 days of refrigerated storage in non-DEHP storage bags. The 3 parts of FDA RBC recovery criteria that must be met (below) are presented in Primary Outcome 1 and Primary Outcome 2. The derivation of the sample size was based on the level of precision attained with 26 subjects relative to the 1st part of the criteria.
| The Evaluable Analysis Population includes all participants who completed all study visits per the CIP with valid 24-hour recovery endpoint(s) for the single-label (25 evaluable data points) and dual-label (24 evaluable data points) methods without having met any of the protocol analysis exclusion criteria described in the CIP. | Posted | Mean | Standard Deviation | % 24-hr RBC Recovery | 43 days |
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| 0 |
| 30 |
| 0 |
| 30 |
| 6 |
| 30 |
| Puncture site haematoma | General disorders | MedDRA version 28.0 | Systematic Assessment |
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Available upon request.