Status:
WITHDRAWN
Clinical Investigation to Evaluate the Hemanext® Red Blood Cell Processing System for Extended Storage of Leukoreduced Red Blood Cells
Lead Sponsor:
Hemanext
Conditions:
Whole Blood Donations and Leukoreduction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary goal of Hemanext Inc. is to improve the safety and efficacy of transfusion therapy through novel storage methods potentially improving their quality across the storage cycle. Based on our ...
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.
- 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 :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04418934
Start Date
July 1 2020
End Date
May 1 2021
Last Update
August 3 2020
Active Locations (2)
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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, 23510