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 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.

In vitro and in vivo performance of O2/CO2 reduced red blood cells produced with the Hemanext System will be used to demonstrate the acceptability the final product for clearance. To accomplish this, the study will require a total of 100 studyevaluable donors. completing the study. The study entails a randomized, paired, 2-x-2 crossover design where every study donor (n = 10093) evaluable study donors who completes the study will donate a total of two whole blood units with individual units being donated at least 56 days (8 weeks) apart. One unit will be used as the test and the other unit will be used for the control. The order in which the IP and the CP will be used to collect, filter and store the whole blood and appropriate blood products (within the context of the crossover design) will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* 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.

  21 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.

Exclusion Criteria:

* 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.