Using cold stored platelets for patients undergoing cardiac surgery

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

This study tests if using cold stored platelets can help patients having heart surgery who are bleeding and need transfusions, to see if it works better than regular platelets stored at room temperature.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Bloodworks (other)
• Locations: 1 site (Seattle, Washington)
• Trial ID: NCT05220787 on ClinicalTrials.gov

What this trial studies

This trial evaluates the feasibility and efficacy of using cold stored platelets (CSP) in cardiac surgery patients who are actively bleeding and require transfusions. The study compares CSP, stored at 1-6°C for 10-14 days, to room temperature stored platelets (RSP), which are limited to 7 days of storage. The goal is to determine if CSP can improve bleeding control and reduce the need for surgical re-exploration due to hemorrhage. The study is particularly focused on patients undergoing complex cardiac surgeries that involve cardiopulmonary bypass, where platelet function is compromised.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 scheduled for complex cardiac surgeries involving cardiopulmonary bypass.

Not a fit: Patients with a history of severe transfusion reactions or those not undergoing the specified types of cardiac surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved bleeding management and reduced mortality in cardiac surgery patients.

How similar studies have performed: Previous small pilot trials have shown mixed results regarding the efficacy of cold stored platelets, indicating that this approach is still under investigation.

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).

Where this trial is running

Seattle, Washington

• Swedish Medical Center - Cherry Hill — Seattle, Washington, United States (RECRUITING)

Study contacts

• Principal investigator: Moritz Stolla, MD — Bloodworks Northwest
• Study coordinator: Jeffrey Miles, M.S.

Conditions: Hemorrhage, Platelets, Defect, Bleeding, Surgical Blood Loss