Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- * 1. Subject age is greater than or equal to 18 years of age.
- * 2. Subject can speak and read English.
- * 3. Subject weight is greater than 40 kg.
- * 4. Subject is scheduled for redo, triple valve, or complex aortic cardiac surgery with cardiopulmonary bypass.
- * 5. Subject has ability to comprehend and willingness to sign Informed Consent Form (ICF).
- * 6. If female of childbearing potential, must have a negative pregnancy test and agree to use one of the following methods of contraception during the course of study participation: abstinence, intrauterine contraception device, hormonal method, or barrier method.
- * 7. Subject agrees to not participate in another interventional study during study participation.
- * 8. The clinical site can obtain both possible platelet products (CSP and RSP) as needed per the study protocol given the subject's anticipated surgery date.
- * 1. Subject has history of known repeated, severe transfusion reactions.
- * 2. Subject requires washed products, volume reduced products, or products with additive solution.
- * 3. Subject is planned to receive autologous or directed transfusions.
- * 4. Subject has or is expected to require post-surgical ventricular assist device (VAD), hemodialysis, or extracorporeal membrane oxygenation (ECMO) within 24 hours of the Study Treatment Window.
- * 5. Subject is thrombocytopenic (less than 100 x 103 platelets/μL) on most recent measurement.
- * 6. Subject is pregnant or breastfeeding.
- * 7. Subject is a prisoner
- * 8. Subject has active infection.
- * 9. Subject refuses blood products.
- * 10. Subject has a history of unprovoked deep vein thrombosis (DVT) or unprovoked pulmonary embolism (PE).
- * 11. Subject has previously been enrolled and received a study platelet transfusion.
- * 12. Subject has known bleeding diathesis (hemophilia, Von Willebrand Disease, or others)
- * 13. At discretion of subject's physician, Sub-Investigator (SI), or Principle Investigator (PI).
Ages Eligible for Study
18 Years to 100 Years
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No