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Evaluation of Whole Blood With CPD Anticoagulant and AS-7/SOLX Additive Solution

NCT02145507 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2022-04-25

Study results available
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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).

Conditions

  • Blood Donors

Interventions

DRUG

SOLX (Investigational)

SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.

DRUG

AS-3 (Control)

AS-3 solution is regulated as a drug but is not intended to provide a direct therapeutic benefit

Sponsors & Collaborators

  • Haemonetics Corporation

    lead INDUSTRY

Principal Investigators

  • Lou A Maes, MD · ARC Mid-Atlantic Region Blood Services

  • Jose Cancelas, MD · Hoxworth Blood Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02145507 on ClinicalTrials.gov