Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients

Launched by MORITZ STOLLA, MD · Jan 21, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of cold-stored platelets for patients undergoing heart surgery who are experiencing bleeding and need platelet transfusions. The researchers want to see if platelets that have been stored at cooler temperatures (1-6°C) for up to two weeks can be safely and effectively used in these cases. The goal is to determine if this method can help reduce bleeding during and after surgery.

To participate in this trial, you need to be at least 18 years old, weigh more than 40 kg, and be scheduled for specific types of heart surgeries, such as complex aortic surgeries or valve replacements. You also must be able to read and speak English and agree to participate by signing a consent form. Participants will receive either the cold-stored platelets or standard platelets as part of the study. It’s important to know that certain conditions, like a history of severe reactions to blood transfusions or being pregnant, may prevent you from joining the trial. If you qualify and decide to participate, you'll have a dedicated team to monitor your safety throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• Exclusion Criteria:
• • 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).