Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03991481
PHASE3

The Cryopreserved vs. Liquid Platelets Trial

Sponsor: Australian and New Zealand Intensive Care Research Centre

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

388

Start Date

2021-08-17

Completion Date

2025-11

Last Updated

2025-01-03

Healthy Volunteers

No

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

Locations (6)

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

The Prince Charles Hospital

Brisbane, Queensland, Australia

Townsville Hospital

Douglas, Queensland, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia