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The Cryopreserved vs. Liquid Platelets Trial

NCT03991481 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2025-01-03

No results posted yet for this study

Summary

This trial is a phase III multicentre blinded randomised controlled clinical non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of surgical bleeding. The aim of the study is to assess the efficacy, safety and cost effectiveness of cryopreserved platelets, compared to conventional liquid-stored platelets, for the management of surgical bleeding. This trial will recruit cardiac surgical patients deemed to be at high risk of surgical bleeding and who may potentially require transfusion of platelets. It is estimated to require 808 high-risk cardiac surgical patients to be recruited, to obtain 202 patients who receive transfused study platelets for surgical bleeding.

Conditions

Interventions

BIOLOGICAL

Cryopreserved platelets

Platelets that have undergone a process to freeze, store and reconstitute platelets, extending their expiry to 2 years

BIOLOGICAL

Liquid-stored platelets

Liquid-stored platelets as per standard practice

Sponsors & Collaborators

  • Australian Red Cross

    collaborator OTHER

  • Australian and New Zealand Intensive Care Research Centre

    lead OTHER

Principal Investigators

  • Michael Reade · ANZIC-Research Centre; Australian Defence Force, University of Queensland,

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-17
Primary Completion
2024-07-17
Completion
2025-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991481 on ClinicalTrials.gov