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Autologous Cold-stored Apheresis Platelets

Study acronym: Auto-PLTS
StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2026 → Dec 31, 2027
See other at-risk trials from University Health Network, Toronto

Record History

  1. Primary completion pushed from Dec 31, 2026 to Dec 31, 2027 Recruitment opened · Start date changed from estimate of Sep 1, 2025 to Sep 28, 2026 · Completion pushed from Apr 30, 2027 to Apr 30, 2028 · 2 more Show 5 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Sep 1, 2025 to Sep 28, 2026
    • Completion pushed from Apr 30, 2027 to Apr 30, 2028
    • Eligibility criteria expanded, about 10 words
    • Site details revised
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07064954
Lead Sponsor University Health Network, Toronto
Conditions Bleeding, Platelets, Cardiopulmonary Bypass, Cardiac Surgery
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov