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NCT02145507 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution
A Phase 1 study, sponsored by Haemonetics Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 170
- Enrollment target
NCT02145507: Completed Phase 1 study, sponsored by Haemonetics Corporation.
NCT02145507 is a Phase 1 study that has completed, run by Haemonetics Corporation. The registered enrollment target is 170 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (183% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02145507, a Phase 1 study, has completed, sponsored by Haemonetics Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 170 participants
- Enrollment target
Study Summary
This study will evaluate a new blood collection and filtration system that is intended to be used to collect, filter, separate and store red blood cells and, separately, plasma. The new blood collection and filtration system will be compared to an already-approved and currently used system. Further, this study will evaluate new processing conditions relative to the individual components of the collection and filtration system. All study participants will donate two units of whole blood with individual units being donated at least 56 days apart. One unit of whole blood will be donated with the new system, and the other unit will be collected with the already-approved system. A subset of the donors (approximately 24 of the 120 participants) will have a small quantity of their red blood cells injected back into their body 42-days after they were donated in order to evaluate how well the red blood cells survive. Blood and blood products from all donors will be analyzed the day of collection and after storage (plasma after at least 30 days of storage and red blood cells after exactly 42 days of storage).
Primary Outcome
The percent of recovered red blood cells when the content of pre-filtration whole blood is compared to the post-filtration leukoreduced whole blood content.
Interventions
- DRUG SOLX (Investigational)
- DRUG AS-3 (Control)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 170 participants |
| Start Date | 2014-04 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
What the finished NCT02145507 record still lists
NCT02145507 is an interventional study that assigns participants to a tested intervention. The registered 170 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (183% higher).
The record links to 0 conditions, and to 2 interventions - of which SOLX (Investigational) is the first listed.
NCT02145507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02145507 about?
NCT02145507 is a clinical study titled "Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution". This study will evaluate a new blood collection and filtration system that is intended to be used to collect, filter, separate and store red blood cells and, separately, plasma. The new blood collection and filtration system will be compared to an already-approved and currently used system. Further,...
What is the current status of trial NCT02145507?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 170 participants. The study started on 2014-04. Estimated completion is 2015-01.
What interventions are being tested in trial NCT02145507?
The interventions under investigation include: SOLX (Investigational) (DRUG), AS-3 (Control) (DRUG).
Who is sponsoring clinical trial NCT02145507?
This trial is sponsored by Haemonetics Corporation, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02145507's enrollment target sits among peer trials
170 325th of 2000 higher than 1,675 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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