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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03991481




Registration number
NCT03991481
Ethics application status
Date submitted
9/05/2019
Date registered
19/06/2019

Titles & IDs
Public title
The Cryopreserved vs. Liquid Platelets Trial
Scientific 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
Secondary ID [1] 0 0
ANZIC-RC/MR002
Universal Trial Number (UTN)
Trial acronym
CLIP II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Blood Loss 0 0
Hemorrhage 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Cryopreserved platelets
Treatment: Other - Liquid-stored platelets

Experimental: Cryopreserved platelets - Platelets that have undergone a process to freeze, store and reconstitute platelets, extending their expiry to 2 years

Active comparator: Liquid-stored platelets - Platelets that have been liquid stored, with an expiry of 5 days.


Treatment: Other: Cryopreserved platelets
Platelets that have undergone a process to freeze, store and reconstitute platelets, extending their expiry to 2 years

Treatment: Other: Liquid-stored platelets
Liquid-stored platelets as per standard practice
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Volume of post-surgical bleeding in the first 24 hours
Timepoint [1] 0 0
First 24 hours from the time of ICU admission
Secondary outcome [1] 0 0
Total volume of post-surgical chest drain bleeding
Timepoint [1] 0 0
From ICU admission up to removal of drains, death or day 28, whichever occurs first
Secondary outcome [2] 0 0
Composite bleeding outcome using the BARC4 criteria
Timepoint [2] 0 0
Up to ICU discharge, death or Day 90, whichever occurs first
Secondary outcome [3] 0 0
Number of units of Packed red blood cells transfused
Timepoint [3] 0 0
in the first 24 hours after admission to ICU
Secondary outcome [4] 0 0
Total number of units of Packed red blood cells transfused
Timepoint [4] 0 0
From operation commencement up to ICU discharge, death or day 90, whichever occurs first
Secondary outcome [5] 0 0
Occurrence of any one of the following pre-specified potential complications
Timepoint [5] 0 0
Up to ICU discharge, death or day 90, whichever occurs first

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
Accrual to date
Final
388
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [3] 0 0
Townsville Hospital - Douglas
Recruitment hospital [4] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [5] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [6] 0 0
Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
4032 - Brisbane
Recruitment postcode(s) [3] 0 0
4814 - Douglas
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Red Cross
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Reade
Address 0 0
ANZIC-Research Centre; Australian Defence Force, University of Queensland,
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
At the completion of the study, at the discretion of the trial Management Committee and Monash University, an extract of the trial data without any patient identifiers may be made available on a case-by-case basis to investigators from reputable research organisations with a defined protocol and analysis plan, using the principles to protect patient anonymity described by the UK Medical Research Council. In accordance with the Australian \& New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG) Terms of Reference for an endorsed trial, the CTG Chair must approve sharing of data with any third party, manuscripts derived from shared data must be submitted for CTG endorsement prior to publication and must acknowledge the role of the CTG in the original study, and a copy of the published manuscript must be provided to the CTG office.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
De-identified data availability will begin 9 months after publication of the individual patient data meta-analysis combining both trial results, and end 36 months after this publication.
Available to whom?
Submissions to use data with investigators from reputable research organisations with a defined protocol and analysis plan, using the principles to protect patient anonymity described by the UK Medical Research Council.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03991481