MedTrace Logo

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

NCT03301779 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-06-23

Study results available
· View outcomes & findings →

Summary

The primary goal of Hemanext. is to improve red cell storage through novel storage methods. Based on our review of the pertinent literature, there is substantial evidence suggesting that prolonged exposure to oxygen during storage results in oxidative damage to the red blood cells leading to decreased therapeutic potential. Therefore, removal of oxygen from red blood cell products prior to storage has potential to preserve the cells in a more physiologically relevant state.

Currently, Hemanext has focused on the design and development of a dual compartment bag system designated as the Hemanext Red Blood Cell Processing System. After standard processing of donated whole blood units into leukoreduced packed red blood cells (LR-RBCs) with the appropriate additive solutions, the LR-RBCs would then be placed in the oxygen reduction bag (ORB) which allows for the rapid diffusion of oxygen out of the blood, through a sterile, oxygen-permeable membrane, and into iron-based oxygen sorbents. After processing, the blood is transferred again from the ORB into the Hemanext storage bag (HSB) which will preserve the anaerobic state of the LR-RBC product for the duration of cold storage.

Hemanext has conducted preliminary storage tests to ascertain the effects of anaerobic storage on overall blood health in various storage solutions. The research team has focused primarily on percent hemolysis, which is mandated by the FDA to remain below 1% for the duration of storage, as well as ATP and 2,3-DPG levels.

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.

Sponsors & Collaborators

  • Hemanext

    lead INDUSTRY

Principal Investigators

  • Faye West, MD · American Red Cross Mid-Atlantic Research Facility

  • Jose A Cancelas Perez, MD, PhD · Hoxworth Blood Center

  • Matthew Karafin, MD · Versiti

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-27
Primary Completion
2019-03-06
Completion
2019-03-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03301779 on ClinicalTrials.gov