Autologous Cold-stored Apheresis Platelets

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Auto-PLTS Study, is looking at a new way to help patients who are having planned complex heart surgery. Normally, patients receive donated platelets from other people to help with bleeding during and after surgery. This study is testing whether using a patient’s own platelets—collected ahead of time and stored in a special cold condition—can be just as safe and helpful. Using a patient’s own platelets might reduce the need for donated platelets from others, which can help the healthcare system and possibly improve patient outcomes.

Adults who are having certain types of planned heart surgeries involving multiple heart valves, the aorta, or coronary artery bypass grafts may be eligible to join. To participate, patients need to be able to donate their platelets about 7 to 10 days before surgery, so their body has time to recover. People with low platelet counts, certain heart conditions, infections, or who are on some blood-thinning medications may not be able to join. If eligible, participants will donate their platelets before surgery, and then doctors will use these stored platelets during their operation instead of donated ones from others. This study will help researchers understand if patients are willing to donate their own platelets ahead of surgery and if this approach works well for heart surgery patients.

Gender

ALL

Eligibility criteria

• 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