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NCT06602804 · ClinicalTrials.gov registry record · NA
Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study
A NA study of Device Validation of In-vivo Performance, sponsored by Terumo BCT.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
- 2
- Study locations
NCT06602804: Completed NA study of Device Validation of In-vivo Performance, sponsored by Terumo BCT.
NCT06602804 is a NA study of Device Validation of In-vivo Performance that has completed, run by Terumo BCT. The registered enrollment target is 37 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06602804, a NA study of Device Validation of In-vivo Performance, has completed, sponsored by Terumo BCT.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
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 par
Conditions Studied
Interventions
- DEVICE Trima Accel Auto RBC Collection
Study Locations (2)
Ohio
- Hoxworth Blood Center, University of Cincinnati College of Medicine - Cincinnati
Virginia
- American Red Cross, Norfolk Clinical Research Lab - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2024-08-26 |
| Est. Completion | 2025-01-31 |
| Phase | NA |
What the finished NCT06602804 record still lists
NCT06602804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Device Validation of In-vivo Performance appearing as the primary indexed condition, and to 1 intervention - of which Trima Accel Auto RBC Collection is the first listed.
NCT06602804 reports a single indexed study location in Ohio, Virginia.
Frequently Asked Questions
What is clinical trial NCT06602804 about?
NCT06602804 is a clinical study titled "Trima Non-DEHP Leukoreduced Red Blood Cell In Vivo Recovery Study". 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.
What is the current status of trial NCT06602804?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2024-08-26. Estimated completion is 2025-01-31.
What conditions does trial NCT06602804 study?
This clinical trial studies the following conditions: Device Validation of In-vivo Performance.
What interventions are being tested in trial NCT06602804?
The interventions under investigation include: Trima Accel Auto RBC Collection (DEVICE).
Who is sponsoring clinical trial NCT06602804?
This trial is sponsored by Terumo BCT, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06602804 being conducted?
This trial has 2 study locations across Ohio, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06602804's enrollment target sits among peer trials
37 1540th of 2000 higher than 460 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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