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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT02006368
Eligibility Criteria:
Inclusion Criteria:
* The subject is in good health, is taking no excluded medications, and satisfies the Blood Center's criteria to donate blood products. Criteria will also include the following guidelines:
* Meets whole blood/platelet donor suitability requirements as defined in 21 CFR 640.3 and set forth by the AABB (Reference Standard 5.4.1A, 2006). Past travel restrictions do not apply for this study.
* Weight ≥50 kg (110 pounds)
* Hemoglobin/hematocrit: ≥12.5 g/dL/38%
* Temperature: less than or equal to 37.5 degrees C
* Resting blood pressure: systolic less than or equal 180 mmHg; diastolic ≥100 mmHg
* Resting heart rate: 50 to 100 beats per minute
* Age ≥ 18 years, of either sex;
* Able to read, understand and sign the informed consent document and commit to the study follow-up schedule;
* Subjects must have good veins for whole blood collection and follow-up blood draws;
* Subjects of child-bearing potential must agree to use an effective contraceptive during the course of the study;
* Those subjects who will be reinfused within 10 days of their 500 mL WB collection must meet the criteria for donating a double RBC unit to accommodate the sampling volume that will occur shortly thereafter:
* Male subjects must weigh a minimum of 130 lbs and be at least 5'1" tall
* Female subjects must weigh a minimum of 150 lbs and be at least 5'5" tall
* Both male and female subjects must have a Hematocrit of ≥ 40%;
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;
* Taking aspirin, Alka-Seltzer™, clopidogrel, or other "anti-platelet" drugs within 7 days prior to donation.
* Taking any nonsteroidal anti-inflammatory drug (for example: Motrin™, Advil™, or ibuprofen) within 3 days prior to donation.
* Taking any anticoagulant medications (for example Coumadin, dabigatran, rivaroxaban or any medications chemically related to heparin).
* Currently pregnant or nursing within the 6 weeks prior to enrollment as assessed during interview. Current status is confirmed by pregnancy test prior to radioisotope infusion.
* Inability to comply with the protocol in the opinion of the investigator.
* Participation in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical);
* Have participated in ≥ 4 research studies involving radioisotopes within the last 12 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02006368
Study Brief:
Protocol Section:
NCT02006368