Autologous Cold-stored Apheresis Platelets

NCT ID: NCT07064954

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-04-30

Brief Summary

The Auto-PLTS Study is a single-centre trial performed at Toronto General Hospital (TGH) that uses a randomized, patient preference design. The recent introduction of cold-stored platelets with a shelf-life of 14 days into clinical practice has made it possible to offer autologous apheresis platelet predonation to patients undergoing elective cardiac (and other high-blood-loss) surgeries while allowing sufficient time to recover platelet count before surgery. The Auto-PLTS Study is designed to assess whether replacing allogeneic platelets with autologous platelets will improve patient outcomes and benefit the healthcare system by reducing the burden on allogeneic platelet supply. The study is also designed to determine whether patients are willing to donate autologous platelets 7-10 days prior to surgery.

Conditions

Bleeding; Platelets; Cardiopulmonary Bypass; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

Patients in the intervention group will undergo autologous collection of 2 units of apheresis platelets 7-10 days before surgery during their preadmission visit. The collected autologous platelets will be cold-stored at 1-6°C until the time of surgery. Patients will receive their own autologous platelets during or after surgery in response to excessive bleeding in the setting of low platelet count or function.

Group Type: EXPERIMENTAL

Autologous Cold-Stored Platelets

Intervention Type: BIOLOGICAL

Two units of autologous platelets will be collected via an apheresis machine that draws blood from an intravenous (IV) line over 1-2 hours, isolates and leukoreduces the platelets by centrifugation and returns the remaining blood back to the patients. Collected autologous platelets will be stored at 1-6℃ without agitation until they are needed during or after surgery or 14 days have elapsed since their collection, after which they will be destroyed as per standard institutional procedures for expired blood products. For the first two platelet orders within 24 hours of cardiopulmonary bypass (CPB) termination, patients will receive their autologous cold-stored platelets. For the third and subsequent doses, patients in the intervention group will receive allogeneic room temperature-stored platelets (standard of care).

Control Group

Patients in the control group will receive standard, Health Canada approved, allogeneic platelets supplied by the Canadian Blood Services (stored at room temperature for up to 7 days) during or after surgery in response to excessive bleeding in the setting of low platelet count or function.

Group Type: ACTIVE_COMPARATOR

Allogeneic Room Temperature-Stored Platelets (Standard of Care)

Intervention Type: BIOLOGICAL

Allogeneic platelets will be collected by Canadian Blood Services as per their standard operating procedures. Room temperature stored platelets will be stored at 20-24°C with constant agitation for up to 7 days as per current practices. For any platelet orders within 24 hours of cardiopulmonary bypass (CPB) termination, patients in the control group will receive allogeneic platelets as per usual care.

Interventions

Autologous Cold-Stored Platelets

Two units of autologous platelets will be collected via an apheresis machine that draws blood from an intravenous (IV) line over 1-2 hours, isolates and leukoreduces the platelets by centrifugation and returns the remaining blood back to the patients. Collected autologous platelets will be stored at 1-6℃ without agitation until they are needed during or after surgery or 14 days have elapsed since their collection, after which they will be destroyed as per standard institutional procedures for expired blood products. For the first two platelet orders within 24 hours of cardiopulmonary bypass (CPB) termination, patients will receive their autologous cold-stored platelets. For the third and subsequent doses, patients in the intervention group will receive allogeneic room temperature-stored platelets (standard of care).

Intervention Type: BIOLOGICAL

Allogeneic Room Temperature-Stored Platelets (Standard of Care)

Allogeneic platelets will be collected by Canadian Blood Services as per their standard operating procedures. Room temperature stored platelets will be stored at 20-24°C with constant agitation for up to 7 days as per current practices. For any platelet orders within 24 hours of cardiopulmonary bypass (CPB) termination, patients in the control group will receive allogeneic platelets as per usual care.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Toronto General Hospital - University Health Network

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Keyvan Karkouti, MD

Role: CONTACT

ACTU@uhn.ca

416-340-4800 ext. 4221

Deep Grewal

Role: CONTACT

ACTU@uhn.ca

416-340-4800 ext. 4221

Facility Contacts

Justyna Bartoszko, MD MSc FRCPC

Role: primary

Justyna.Bartoszko@uhn.ca

(416) 340-4800 ext. 3243

Other Identifiers

24-5285

Identifier Type: -

Identifier Source: org_study_id