Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients

Description

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) in cardiac surgery patients who are actively bleeding and require platelet transfusion.

Conditions

Hemorrhage, Platelets; Defect, Bleeding, Surgical Blood Loss

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Study Overview

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Study Details

Study overview

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) in cardiac surgery patients who are actively bleeding and require platelet transfusion.

Evaluation of Efficacy and Safety of Extended Cold Stored Apheresis Platelets Versus Conventional Apheresis Platelets in Cardiac Surgery Patients

Extended Cold Stored Apheresis Platelets in Cardiac Surgery Patients

Condition
Hemorrhage
Intervention / Treatment

-

Contacts and Locations

Seattle

Swedish Medical Center - Cherry Hill, Seattle, Washington, United States, 98122

Participation Criteria

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

Collaborators and Investigators

Moritz Stolla, MD,

Moritz Stolla, MD, PRINCIPAL_INVESTIGATOR, Bloodworks Northwest

Study Record Dates

2024-10-29