At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Investigation to Evaluate the Haemonetics LeukoSep Leukocyte Reduction Filtration System for Whole Blood With CPD Anticoagulant and SOLX Additive - Pivotal Trial
In Brief
A Phase 1 clinical trial evaluating SOLX (Investigational) and AS-3 (Control) for Blood Donors. Completed, enrolled 170 participants across 2 sites.
Detailed 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).
Study Details
Timeline
Interventions
SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit