The Cryopreserved vs. Liquid Platelets Trial (CLIP II)

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    808
  • sponsor
    Australian and New Zealand Intensive Care Research Centre
Updated on 4 October 2022

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.

Description

For logistic reasons and in order to use this scarce resource optimally, liquid-stored platelets are not stored in smaller hospitals, or in deployed military hospitals. Patients in these hospitals therefore currently have limited or no access to platelet transfusion. Cryopreservation of platelets is a promising technology that would allow smaller hospitals to provide platelet transfusions, reduce overall platelet wastage, and possibly produce better patient outcomes through more effective haemostasis.

This 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. The study will recruit patients in Australian tertiary hospitals.The study hypothesis is that cryopreserved platelets will be at least as effective as conventional liquid-stored platelets in the treatment of active bleeding due to surgery.

Details
Condition Surgical Blood Loss, Hemorrhage
Treatment Cryopreserved platelets, Liquid-stored platelets
Clinical Study IdentifierNCT03991481
SponsorAustralian and New Zealand Intensive Care Research Centre
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cardiac surgery patients identified preoperatively as having a high risk of platelet transfusion by either
the ACSePT (Australian Cardiac Surgery Platelet Transfusion (score)) risk prediction tool score ≥1 OR
the judgement of the clinicians caring for the patient
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
preoperative platelet count <50 000 or
INR (International Normalised Ratio) >2 or
aPTT (Activated Partial Thromboplastin Time) > 2 x upper limit of normal
Treatment with warfarin, IV heparin or low-molecular weight heparin at "full
Known allergy to dimethylsulphoxide (DMSO)
therapeutic anticoagulant doses, or other anticoagulant or anti-platelet
medications such as factor Xa inhibitors (rivaroxaban, apixaban); factor II
Planned presence of an arterial line and central venous catheter for less than 12 hours postoperatively
Known objection to receipt of human blood components
inhibitors (dabigatran); adenosine diphosphate receptor inhibitors
The treating physician believes it is not in the best interest of the patient to be randomised in this trial
(clopidogrel, prasugrel, ticagrelor, ticlopidine); glycoprotein IIB/IIIA
Previous enrolment during this admission in a clinical trial of a medication or technique thought to influence bleeding, with the exception of any trial of aspirin (i.e. trials involving aspirin are permitted), OR previous enrolment in a clinical trial with a protocol that affects the transfusion of blood products
inhibitors (abciximab, eptifibatide, tirofiban); phosphodiesterase inhibitors
Previous enrolment in this study
(cilostazol); or adenosine reuptake inhibitors (dipyridamole) UNLESS this
medication has been discontinued in advance of surgery and its effect allowed
to dissipate
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