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 @ 11:11 PM
Ignite Modification Date:
2025-12-26 @ 11:11 PM
NCT ID:
NCT02310412
Eligibility Criteria:
Inclusion Criteria:
* Age-minimum of 18 years, of either gender
* Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
* Meet FDA and AABB guidelines for autologous apheresis platelet donation
* Complete blood count (CBC) and serum chemistry values within normal limits
* Pre-donation platelet count of more than 150×109 platelets/L
* Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and WNV
* Male and female subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study. A barrier method of contraception must be included, regardless of other methods.
* Signed and dated informed consent form
Exclusion Criteria:
* Clinically significant acute or chronic disease (as determined by the Investigator)
* Pregnant or nursing females
* Male or female subjects of childbearing potential not using effective contraception
* Disease states or conditions that preclude blood donation or apheresis platelet donation per AABB reference standards
* Treatment with aspirin or aspirin containing medications within 7 days of apheresis or treatment with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents or other drugs affecting platelet viability within 3 days of apheresis (e.g. ibuprofen or other NSAIDs)
* Smokers using \>10 cigarettes/day for the last 3 months
* Splenectomized subjects
* Prior exposure to amotosalen
* History of known hypersensitivity to indium or chromium
* Participation in another clinical study currently or within the past 28 days
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02310412
Study Brief:
Protocol Section:
NCT02310412