Status:
UNKNOWN
Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients
Lead Sponsor:
Moritz Stolla, MD
Collaborating Sponsors:
United States Department of Defense
Conditions:
Hemorrhage
Platelets; Defect
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
This trial is being performed to evaluate the feasibility of the study protocol and to test the efficacy and safety of platelets stored at cold conditions (1-6°C) in 100% plasma for 10-14 days (CSP) i...
Detailed Description
Cardiac surgery featuring cardiopulmonary bypass (CPB) has a detrimental effect on platelet function. Contact with foreign surfaces causes a transient platelet dysfunction. The bleeding time is prolon...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05220787
Start Date
February 21 2022
End Date
October 29 2024
Last Update
July 27 2023
Active Locations (1)
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1
Swedish Medical Center - Cherry Hill
Seattle, Washington, United States, 98122