Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-25 @ 2:18 AM
NCT ID:
NCT04418934
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.
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04418934
Study Brief:
Protocol Section:
NCT04418934