The Cryopreserved vs. Liquid Platelets Trial (NCT03991481) | Clinical Trial Compass
Active — Not RecruitingPhase 3
The Cryopreserved vs. Liquid Platelets Trial
Australia388 participantsStarted 2021-08-17
Plain-language 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.
Who can participate
SexALL
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Inclusion criteria
✓. Cardiac surgery patients identified preoperatively as having a high risk of platelet transfusion by either:
✓. Written informed consent obtained prior to surgery
Exclusion criteria
✕. Aged less than 18 years
✕. Females of child-bearing age (18- 55 years) who are RhD (Rhesus type D)-negative or whose RhD (Rhesus type D) status is unknown
✕. Receipt of platelet transfusion during this hospital admission
✕. Deep Vein Thrombosis or Pulmonary Emboli first diagnosed within the preceding 6 months
✕. More than one lifetime episode of Deep Vein Thrombosis or Pulmonary Emboli
✕. Known inherited or acquired bleeding disorder (e.g. haemophilia, von Willebrand Disease, idiopathic thrombocytopenic purpura, aplastic anaemia, haematological malignancy, chronic liver disease), or any undiagnosed bleeding condition, if (and only if) such a disorder or condition is associated with a significant laboratory abnormality at the time of preoperative screening. i.e.
✕. Treatment with warfarin, IV heparin or low-molecular weight heparin at "full" therapeutic anticoagulant doses, or other anticoagulant or anti-platelet medications such as factor Xa inhibitors (rivaroxaban, apixaban); factor II inhibitors (dabigatran); adenosine diphosphate receptor inhibitors (clopidogrel, prasugrel, ticagrelor, ticlopidine); glycoprotein IIB/IIIA inhibitors (abciximab, eptifibatide, tirofiban); phosphodiesterase inhibitors (cilostazol); or adenosine reuptake inhibitors (dipyridamole) UNLESS this medication has been discontinued in advance of surgery and its effect allowed to dissipate.
What they're measuring
1
Volume of post-surgical bleeding in the first 24 hours
Timeframe: First 24 hours from the time of ICU admission
Trial details
NCT IDNCT03991481
SponsorAustralian and New Zealand Intensive Care Research Centre