17 Feb Cerus INTERCEPT Radiolabeled Platelet Study
This is a platelet transfusion study. The primary purpose of this study is to find out how long platelets treated with the INTERCEPT blood system and stored for up to 5 days remain in your blood after transfusion. The INTERCEPT blood system for platelets is a treatment performed on a unit of platelets to reduce the risk of diseases transmitted by blood transfusions. This study involves using a radioactive material added to your platelets to track platelets in your blood. Your platelets will be collected using an apheresis procedure. Your platelets will be stored for 5 days. A radioactive material will be added to a small amount of your stored platelets. Your radiolabeled platelets will be given back to you and follow-up blood draws will be done to see how many of your platelets are circulating.
There will be a total of 9 visits over 34 days. Each study visit lasts from 30 minutes to 3 hours. Study visits will occur at Bloodworks Northwest- 1551 Eastlake Ave. East, Suite 100, Seattle, WA 98102. Participants will be compensated up to $1200.00 for time involved in the study.
Participant Eligibility
Inclusion Criteria:
• At least 18 years of age.
• Be in good health.
• Weigh at least 114 lbs.
• Meet study criteria for an apheresis platelet collection.
• Not be taking medication known to interfere with platelet function such as aspirin, nonsteroidal anti-inflammatory drugs such as ibuprofen (Advil, Motrin) or naproxen (Aleve), or platelet inhibitors given for heart disease.
• Test negative for infectious diseases as part of blood donor screening.
Exclusion Criteria:
• Acute or chronic health conditions that may affect study results.
• Pregnant or nursing females.
• Test positive for cocaine or amphetamine use by urine drug screen test.
• Not have a spleen.
• History of known hypersensitivity to indium or chromium.
• On other investigation drug studies within the past 28 days.
Contact
Patricia Klotz, RN
(206) 568-2238
Additional Study Details
Full Study Title
A Randomized, Multi-center, Controlled, In Vivo Study to Assess the Recovery and Survival of Radiolabeled Autologous INTERCEPT Apheresis Platelet Components Suspended in 100% Plasma Stored for 5 Days
Investigator(s)
Moritz Stolla, MD
Accepts Healthy Volunteers?
Yes
Study Site(s)
Bloodworks NW Research Institute
1551 Eastlake Ave E Suite 100
Seattle, Washington 98102