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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT01907906
Eligibility Criteria:
Inclusion Criteria:
* Eligible whole blood donor
* Age ≥ 18 years, of either sex
* Able to commit to the study follow-up schedule
* Subjects must have adequate bilateral antecubital venous access for WB collection and follow-up blood draws
* Negative screening test panel for infectious diseases
* Subjects of child-bearing potential (female or male) must agree to use effective contraceptive during the course of the study per site guidelines
* Subjects must agree to report adverse events (AEs) during the required reporting period
* Negative direct antiglobulin test (DAT) with subject's RBC
* Negative indirect antiglobulin test (IAT) with subject's serum
Inclusion for radiolabeled reinfusion of LR-pRBC on Day 21 (evaluated the day of, prior to, reinfusion):
* Maintenance of healthy status
* Negative direct antiglobulin test (DAT) with subject's RBC (fresh)
* Negative indirect antiglobulin test (IAT) with subject's serum (fresh) versus autologous stored LR-pRBC
* Negative serum or urine pregnancy test in females
Exclusion Criteria:
* Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months
* Pregnant or nursing females; For women of childbearing potential, negative serum or urine pregnancy tests at the time of WB donation and before the reinfusion are required
* Unable to give informed consent
* Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical)
* Have received an accumulated radiation dose that would exclude them from the study according to the local radiation safety limits established by each institution
* Inability to comply with the protocol in the opinion of the investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01907906
Study Brief:
Protocol Section:
NCT01907906