Status:
COMPLETED
Clinical Investigation to Evaluate the Hemanext® Oxygen Reduction System - Pivotal Trial
Lead Sponsor:
Hemanext
Conditions:
Whole Blood Donation and Leukoreduction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 exp...
Detailed Description
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03301779
Start Date
November 27 2017
End Date
March 6 2019
Last Update
June 23 2020
Active Locations (3)
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1
Hoxworth Blood Center, University of Cincinnati
Cincinnati, Ohio, United States, 45267-0055
2
American Red Cross Mid-Atlantic Research Facility
Norfolk, Virginia, United States, 23507
3
Blood Center of Wisconsin
Milwaukee, Wisconsin, United States, 53233