Autologous Cold-stored Apheresis Platelets (Auto-PLTS)

University Health Network, Toronto

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Platelets; Bleeding

Treatments: Biological: Autologous Cold-Stored Platelets; Biological: Allogeneic Room Temperature-Stored Platelets (Standard of Care)

Study type: Interventional

Funder types: Other

Identifiers

NCT07064954

24-5285

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Biological: Autologous Cold-Stored Platelets

Control Group

Active Comparator group

Description:

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.

Treatment:

Biological: Allogeneic Room Temperature-Stored Platelets (Standard of Care)