Cryopreserved platelets: Platelets that have undergone a process to freeze, store and reconstitute platelets, extending their expiry to 2 years
Liquid-stored platelets: Liquid-stored platelets as per standard practice
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.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. 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
2. Written informed consent obtained prior to surgery
Exclusion Criteria:
1. Aged less than 18 years
2. Females of child-bearing age (18- 55 years) who are RhD (Rhesus type D)-negative or whose RhD (Rhesus type D) status is unknown
3. Receipt of platelet transfusion during this hospital admission
4. Deep Vein Thrombosis or Pulmonary Emboli first diagnosed within the preceding 6 months
5. More than one lifetime episode of Deep Vein Thrombosis or Pulmonary Emboli
6. 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.
7. 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.
8. Known allergy to dimethylsulphoxide (DMSO)
9. Planned presence of an arterial line and central venous catheter for less than 12 hours postoperatively.
10. Known objection to receipt of human blood components
11. The treating physician believes it is not in the best interest of the patient to be randomised in this trial
12. 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.
13. Previous enrolment in this study
Primary outcome measure(s)
Volume of post-surgical bleeding in the first 24 hours — First 24 hours from the time of ICU admission Volume of post-surgical bleeding in the chest drains after cardiac surgery
Trial sites (6)
Facility
City
Region
Status
Royal Prince Alfred Hospital
Sydney
New South Wales
The Prince Charles Hospital
Brisbane
Queensland
Townsville Hospital
Douglas
Queensland
Gold Coast University Hospital
Southport
Queensland
St Vincent's Hospital Melbourne
Fitzroy
Victoria
Austin Hospital
Heidelberg
Victoria
More Australian and New Zealand Intensive Care Research Centre trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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