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:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-24 @ 10:54 PM
NCT ID:
NCT03737669
Eligibility Criteria:
Inclusion Criteria:
* Willing to participate in study and patient or legally authorized representative has given written informed consent (IC)
* Hemoglobin \< 7 g/dL or decision to transfusion by clinical team
* Transfusion necessary based on clinical judgment of attending physician
* Agree to return to the hospital for the follow-up visits
Exclusion Criteria:
* Presence of red cell alloantibodies
* Incompatible red cell crossmatch
* Not expected to survive for 10 weeks
* Expected to require plasma or platelets within next 10 weeks outside of the FWB provided in the trial
* Blood type AB (due to concern of limited supply)
* Weight \< 30 kg (due to concern for sufficient blood draws to detect bacteria and other TTIs)
* HIV-infected
* Clinical suspicion of sepsis
* Anti-malarial treatment within 7 days prior to randomization
* Fever (central body temperature greater than 38.5°C)
* Transfusion(s) of a blood product within 1 month prior to randomization
* Acute or chronic medical disorder that, in the opinion of the investigator, would impair the ability of the patient to receive protocol treatment
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03737669
Study Brief:
Protocol Section:
NCT03737669