Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06147531

Delayed Cold-Stored Platelets -PLTS-1

Led by University Health Network, Toronto · Updated on 2025-12-29

150

Participants Needed

2

Research Sites

129 weeks

Total Duration

On this page

Sponsors

U

University Health Network, Toronto

Lead Sponsor

K

Kingston Health Sciences Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

PLTS-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after CPB), as well as safety.

CONDITIONS

Official Title

Delayed Cold-Stored Platelets -PLTS-1

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older undergoing elective cardiac surgery with cardiopulmonary bypass
  • Planned surgery must be at least moderately complex, including valve repair/replacement, aorta replacement, combined coronary artery bypass grafting, or re-do cardiac procedures
  • Preoperative platelet count of 150,000 x10^6/L or lower
Not Eligible

You will not qualify if you...

  • Cold-stored platelets unavailable at time of surgery
  • Congenital or acquired bleeding disorders including platelet refractoriness and need for specially matched platelets
  • Known contraindication to heparin or use of non-reversible anticoagulants
  • Use of warfarin or direct oral anticoagulants within 3 days prior to surgery
  • Use of antiplatelet drugs within 5 days prior to surgery (except aspirin)
  • Refusal of allogeneic blood products
  • Known pregnancy
  • Previous enrollment in this study
  • Participation in another interventional clinical trial altering routine care
  • Hemodynamic instability requiring critical care or vasoactive drugs before surgery
  • Preoperative or expected postoperative dependence on mechanical circulatory support

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Kingston Health Sciences Centre

Kingston, Ontario, Canada, K7L 2V7

Actively Recruiting

2

Toronto General Hospital - University Health Network

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

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Research Team

K

Keyvan Karkouti, MD

CONTACT

D

Deep Grewal

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Delayed Cold-Stored Platelets -PLTS-1 | DecenTrialz