Autologous Cold-Stored Platelets for Complex Cardiac Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Auto-PLTS study at Toronto General Hospital compares autologous, cold-stored platelets to standard allogeneic platelets in adults undergoing elective complex cardiac surgery. It uses a randomized, patient-preference design to see if autologous platelets can reduce reliance on donor platelets and improve surgical outcomes. Platelets are collected via apheresis and stored cold for up to 14 days before use in surgery. The trial aims to determine feasibility of autologous donation and its potential impact on patient recovery and healthcare resource use. Enrollment is limited to patients meeting specific high-risk cardiac surgery criteria and who can donate within a 7–10 day window before surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Adult (≥18 years old) patients who meet all following criteria:

1\. Undergoing elective complex cardiac surgery consisting of at least one of the following:

* Repair or replacement of more than one valve (i.e., multiple valves)
* Repair or replacement of any segment of aortic arch
* At least two of any combination of coronary artery bypass grafting (CABG), valve repair/replacement, or aorta (ascending/arch) repair/replacement
* Complex adult congenital repair

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

1. Seven days or less from recruitment to surgery (as there will not be sufficient time from platelet donation to surgery for patients to recover their platelet count)
2. Patient factors that preclude platelet donation or increase risk of adverse events after donation, including any of the following:

   * Poor intravenous access
   * Low baseline platelet count (≤150,000 x106/L)
   * Low baseline hemoglobin (\<100 g/L) (since approximately 50 mL of red blood cells are lost with each unit of apheresis platelet collection)
   * Inability to tolerate fluid shifts during donation (i.e., severe aortic stenosis with valve area \<0.7 cm2, or left main coronary artery stenosis \>80%, or left ventricular ejection fraction \<30%)
   * Increased risk of bacterial contamination of collected units (i.e., active infection, on antibiotics, dental procedure \<72 hours before donation)
   * Attending clinicians deem the patient ineligible for autologous predonation
   * Known positivity for active infectious blood-borne disease (HIV, HCV, HBV, HTLV, Syphilis)
3. Highly specialized procedures such as insertion or removal of ventricular assist devices or repair of thoracoabdominal aneurysm
4. Any history of congenital or acquired bleeding disorder (including any type of thrombocytopenia or platelet refractoriness due to anti-platelet and anti-HLA antibodies or requirement for specially matched platelets)
5. On any anticoagulant or antiplatelet medications, excluding ASA, that cannot be stopped at least 7 days before donation (72 hours for NSAIDs)
6. Refusal of allogeneic blood products due to religious or other reasons
7. Known or suspected pregnancy

Where it's running

• Toronto General Hospital - University Health Network
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Keyvan Karkouti, MD
• Email: ACTU@uhn.ca
• Phone: 416-340-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.