None listed
Conditions
Brief summary
The CLiPNZ-II trial is a prospective, multi-centre, blinded, randomised non-inferiority trial of cryopreserved platelets vs. conventional liquid-stored platelets for the management of surgical bleeding. Participants will be randomised to either: Cryopreserved (CPS) platelets (intervention arm) or Conventional liquid-stored (RTS) platelets (usual care arm). The aim of this study is to assess the efficacy, safety and cost-effectiveness of cryopreserved platelets compared to conventional liquid stored platelets, Effective cryopreserved storage would allow smaller hospitals to provide platelet transfusion, reduce overall platelet wastage, and possibly produce better patient outcomes.
Interventions
Cryopreserved (CPS) platelets (intervention arm): Cryopreserved group O (low antibody titre – i.e. universal donor) platelets will be prepared NZ Blood Service staff using the approved methodology in the hospital blood bank
The treating clinician and clinical staff are blinded to the study group allocation. Transfusion indication, timing and number of platelets will be determined by treating clinicians.
Platelet transfusion will begin in either the operating theatre or ICU (but must occur with
Cryopreserved (CPS) platelets (intervention arm): Cryopreserved group O (low antibody titre – i.e. universal donor) platelets will be prepared NZ Blood Service staff using the approved methodology in the hospital blood bank The treating clinician and clinical staff are blinded to the study group allocation. Transfusion indication, timing and number of platelets will be determined by treating clinicians. Platelet transfusion will begin in either the operating theatre or ICU (but must occur within 24hrs of ICU admission). When a clinical decision is made to transfuse platelets, the ordering clinician will request platelets from the blood bank according to usual local hospital policy. New Zealand Blood Service has developed a novel method of manufacturing cryopreserved platelets, this method doesn't require any washing of platelets and the thawing and reconstitution in plasma is simplified by the use of a two-chamber bag. Cryopreservation of platelets increases the shelf life to 2 years by keeping the platelets frozen at -80C
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Cardiac surgery patients identified preoperatively as having a high risk of platelet transfusion by either: - the ACSePT risk prediction tool (score of 1 or higher) OR - the judgement of the clinicians caring for the patient 2. Written informed consent obtained prior to surgery
Exclusion criteria
1. Aged less than 16 years 2. Females of child-bearing age (16- 55 years) who are RhD-negative or whose RhD status is unknown 3. Previous receipt of platelet transfusion during this hospital admission 4. DVT or PE first diagnosed within the preceding 6 months 5. More than one lifetime episode of DVT or PE 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>2 or - aPTT > 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 enrolled in this trial 12. Previous enrolment in a clinical trial of a medication or technique thought to influence bleeding during this admission, with the exception of any trial of aspirin 13. Previous enrolment in this study.
Outcome results
None listed