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

NCT03301779 | Completed Phase 2 Results FDA Device

• 1 other identifier: CLIN-0001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Red Blood Cells

Outcome Measures

Primary Outcomes (3)

• % of Red Blood Cells With Hemolysis

  Percentage of packed Red Blood Cell units with hemolysis at day 42 of storage.

  On day 42 of storage

• Dual Label 24 Hour In Vivo % Recovery of Red Blood Cells

  The mean 24-hour, post-transfusion, in vivo red blood cell recovery.

  Day 42 of storage

• % Red Blood Cells Recovered Post-Filtration

  Percentage of red blood cells recovered after the filtration process.

  Post-Filtration on Day 0

Study Arms (2)

Investigational Product

EXPERIMENTAL

Blood product from these donors will be processed and stored using the Hemanext Red Blood Cell Processing System

Device: Hemanext Red Blood Cell Processing System

Control Product

NO INTERVENTION

Blood product from these donors will be stored in a Haemonetics Leukotrap Whole Blood System.

Interventions

Hemanext Red Blood Cell Processing System DEVICE

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.

Investigational Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Study donor must be ≥ 18 years of age.
• Study donor must be ≥ 110 pounds.
• Study donor's body temperature must be ≤ 37.5°C / 99.5°F (oral).
• Study donor's hemoglobin must be ≥12.5 g/dL if female and ≥13.0 g/dL if male.
• Study donor's hematocrit must be ≥ 38% if female and ≥39% if male.Study participants must meet EITHER hemoglobin or hematocrit criteria.
• Study donor must meet all criteria per respective site's Research Blood Donation Record (BDR).
• Study donor's most recent single RBC unit donation must have been ≥56 days prior to study donation.
• Study donor's most recent double RBC unit donation must have been ≥ 112 days prior to study donation.
• Study donor must have consented to study participation by reviewing and having expressed understanding the site-respective IRB-approved informed consent form prior to undergoing any study related procedures.
• CFR 50
• Study donor's testing results from collected blood does not indicate a risk of transfusion-transmitted disease (TTD)\*.
• Study donors must agree to report adverse events from the time of signing the informed consent to twenty-four hours following the end of their active study involvement.
• Female study donors must not be pregnant, expected to be pregnant or breastfeeding.
• Female donors who participate in the in vivo portion of the study:
• Women of child-bearing age must not be pregnant as determined by a negative pregnancy test prior to each re-infusion. If acceptable by local procedures, post-menopausal or surgically sterile women may be exempt from the pregnancy testing requirement.

You may not qualify if:

• Study donor is \< 18 years of age.
• Study donor \< 110 pounds.
• Study donor's body temperature is \> 37.5°C / 99.5°F (oral).
• Study donor's hemoglobin is \< 12.5 g/dL if female and \< 13.0 g/dL if male.
• Study donor's hematocrit is \< 38% if female and \< 39% if male.
• Study donor does not meet all criteria per respective site's Research Blood Donation Record (BDR).
• Study donor's most recent single RBC unit donation was \< 56 days prior to study donation.
• Study donor's most recent double RBC unit donation was \< 112 days prior to study donation.
• Study donor has not consented to study participation.
• Study donor's testing results from collected blood does indicate a risk of transfusion-transmitted disease (TTD)\*.
• Female donors who participate in the in vivo portion of the study: study donor is pregnant, expected to be pregnant or breastfeeding.

Sponsors & Collaborators

• Hemanext: lead

Study Sites (3)

Hoxworth Blood Center, University of Cincinnati

Cincinnati, Ohio, 45267-0055, United States

Location

American Red Cross Mid-Atlantic Research Facility

Norfolk, Virginia, 23507, United States

Location

Blood Center of Wisconsin

Milwaukee, Wisconsin, 53233, United States

Location

Limitations and Caveats

Disclaimer: The 51-Cr/99-Tc(m) labeling for 14 study subjects occurred without prior RDRC approval and was done at a site that did not meet GMP standards.

Results Point of Contact

• Title: William Iselin
• Organization: Hemanext

william.iselin@hemanext.com

7813017446

Study Officials

• Faye West, MD

  American Red Cross Mid-Atlantic Research Facility

  PRINCIPAL INVESTIGATOR

• Jose A Cancelas Perez, MD, PhD

  Hoxworth Blood Center

  PRINCIPAL INVESTIGATOR

• Matthew Karafin, MD

  Versiti Blood Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 4, 2017
• Study Start: November 27, 2017
• Primary Completion: March 6, 2019
• Study Completion: March 6, 2019
• Last Updated: June 23, 2020
• Results First Posted: March 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)