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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT02476851
Eligibility Criteria:
Eligibility Criteria:
* Study donor must be ≥ 18 years of age.
* Study donor must weigh ≥ 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.
* Study donor's hematocrit must be ≥ 38%.
* 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 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.
* Study donors must not have experienced any of the following:
Physical trauma consistent with associated coagulopathy within the last 30 days, Surgery within the last 30 days, Known history of hypercoagulopathy (i.e., Factor V Leiden, Prothrombin G20210A, idiopathic venous thrombotic events, etc.).
* Female study donors must not be pregnant, expected to be pregnant or breastfeeding.
Exclusion Criteria - any individual not meeting the above criteria.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02476851
Study Brief:
Protocol Section:
NCT02476851