A Randomized, Multi-center, Open-label, Paired Controlled, Crossover In Vivo Study
Stopped early · Phase 2
Conditions studied: Healthy
In brief
The objective of this study is to test the hypothesis that INTERCEPT Blood System for platelet components stored for 6 or 7 days after INTERCEPT Blood System treatment retain sufficient viability for therapeutic efficacy. The post-infusion recovery and lifespan of autologous INTERCEPT Blood System for platelet components in 35% plasma/65% InterSol (Test platelets) stored for 6 or 7 days will be measured in comparison to "fresh" autologous radiolabeled platelets (Control platelets) according to FDA guidance for platelet testing (FDA 1999). Recovery and lifespan results between components stored for 6 and 7 days will also be assessed.
Key facts
- Study ID
- NCT02653443
- Run by
- Cerus Corporation
- People needed
- 14
- Starts
- 2015-12-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2018-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Normal health status (as determined by the Investigator review of medical history and blood donor physical exam)
- Meet FDA, American Association of Blood Banks (AABB), and site guidelines for blood donation or apheresis platelet donation
- Complete blood count (CBC) and serum chemistry values within established reference ranges or within guidelines as above.
- Pre-donation platelet count of more than 150×10\^9 platelets/L
- Negative blood donor screening test panel for Human Immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human T-Lymphotropic virus (HTLV), syphilis, and West Nile virus (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
You may not qualify if…
- 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)
- Subject received platelet inhibitor within 14 days of donation (e.g. clopidogrel, ticlopidine)
- Splenectomized subjects
- History of known hypersensitivity to indium or chromium
- Participation in another clinical study currently or within the past 28 days
Where it is running
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- Hoxworth Blood Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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