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NCT03301779 · ClinicalTrials.gov registry record · Phase 2
Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial
A Phase 2 study of Whole Blood Donation and Leukoreduction, sponsored by Hemanext.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT03301779 is a Phase 2 study of Whole Blood Donation and Leukoreduction that has completed, run by Hemanext. The registered enrollment target is 100 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT03301779, a Phase 2 study of Whole Blood Donation and Leukoreduction, has completed, sponsored by Hemanext.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
Study 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 Studied
Interventions
- DEVICE Hemanext Red Blood Cell Processing System
Study Locations (3)
Ohio
- Hoxworth Blood Center, University of Cincinnati - Cincinnati
Virginia
- American Red Cross Mid-Atlantic Research Facility - Norfolk
Wisconsin
- Blood Center of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2019-03-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03301779
The ClinicalTrials.gov registry entry for NCT03301779 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hemanext, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Whole Blood Donation and Leukoreduction appearing as the primary indexed condition, and to 1 intervention - of which Hemanext Red Blood Cell Processing System is the first listed.
NCT03301779 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Ohio, Virginia, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT03301779 about?
NCT03301779 is a clinical study titled "Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial". 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 decreas...
What is the current status of trial NCT03301779?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2017-11-27. Estimated completion is 2019-03-06.
What conditions does trial NCT03301779 study?
This clinical trial studies the following conditions: Whole Blood Donation and Leukoreduction.
What interventions are being tested in trial NCT03301779?
The interventions under investigation include: Hemanext Red Blood Cell Processing System (DEVICE).
Who is sponsoring clinical trial NCT03301779?
This trial is sponsored by Hemanext, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03301779 being conducted?
This trial has 3 study locations across Ohio, Virginia, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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