Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

November 27, 2017

Primary Completion Date

March 6, 2019

Study Completion Date

March 6, 2019

Conditions
Whole Blood Donation and Leukoreduction
Interventions
DEVICE

Hemanext Red Blood Cell Processing System

Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.

Trial Locations (3)

23507

American Red Cross Mid-Atlantic Research Facility, Norfolk

53233

Blood Center of Wisconsin, Milwaukee

45267-0055

Hoxworth Blood Center, University of Cincinnati, Cincinnati

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Hemanext

INDUSTRY