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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 is a Phase 1 study that has completed, run by Haemonetics Corporation. The registered enrollment target is 170 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02145507
The ClinicalTrials.gov registry entry for NCT02145507 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 170 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Haemonetics Corporation, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which SOLX (Investigational) is the first listed.
NCT02145507 reports 0 study locations.
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.
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