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Surgical Blood LossPhase 3CLIP IINCT03991481

The Cryopreserved vs. Liquid Platelets Trial

A Phase 3 study testing Cryopreserved platelets and Liquid-stored platelets in people with Surgical Blood Loss and Hemorrhage, run by Australian and New Zealand Intensive Care Research Centre at 6 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Surgical Blood Loss, Hemorrhage
What is being tested?
Cryopreserved platelets and Liquid-stored platelets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
388 participants
Where
6 sitesAustralia
Study dates
17 Aug 2021to Nov 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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" 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.
  • Known allergy to dimethylsulphoxide (DMSO)
  • Planned presence of an arterial line and central venous catheter for less than 12 hours postoperatively.
  • Known objection to receipt of human blood components
  • The treating physician believes it is not in the best interest of the patient to be randomised in this trial
  • 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.
  • Previous enrolment in this study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Australia6 sites

  • The Prince Charles Hospital

    Brisbane, Queensland, 4032

  • Townsville Hospital

    Douglas, Queensland, 4814

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

Other trials in Australia

About this study

Official 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

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.

Read the detailed 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.

Being tested
Cryopreserved platelets, Liquid-stored platelets
Medical subject headings
Blood Loss, Surgical, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cryopreserved plateletsBiological

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

  • Liquid-stored plateletsBiological

    Liquid-stored platelets as per standard practice

Study groups in NCT03991481
Study groupRoleWhat they receive
Cryopreserved plateletsExperimentalPlatelets that have undergone a process to freeze, store and reconstitute platelets, extending their expiry to 2 years
Receives: Biological: Cryopreserved platelets
Liquid-stored plateletsActive comparatorPlatelets that have been liquid stored, with an expiry of 5 days.
Receives: Biological: Liquid-stored platelets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volume of post-surgical bleeding in the first 24 hours

    Volume of post-surgical bleeding in the chest drains after cardiac surgery

    Measured: First 24 hours from the time of ICU admission

Secondary outcomes (5)

  1. Total volume of post-surgical chest drain bleeding

    Total volume of post-surgical chest drain bleeding, beginning from the time of ICU admission until drain removal

    Measured: From ICU admission up to removal of drains, death or day 28, whichever occurs first

  2. Composite bleeding outcome using the BARC4 criteria

    Composite bleeding outcome using the Bleeding Academic Research Consortium (BARC4) criteria (intracranial bleeding within 48 hours; reoperation after closure of sternotomy; transfusion of ≥5 Units whole blood or RBCs (red blood cells) within the 48 hour intra- or post-operative period (excluding cell saver blood); chest tube output ≥2 Litres within a 24 hour period)

    Measured: Up to ICU discharge, death or Day 90, whichever occurs first

  3. Number of units of Packed red blood cells transfused

    Number of units of Packed red blood cells transfused in the first 24 hours after admission to ICU

    Measured: in the first 24 hours after admission to ICU

  4. Total number of units of Packed red blood cells transfused

    Total number of units of Packed red blood cells transfused by the time of ICU discharge, including intraoperative transfusion

    Measured: From operation commencement up to ICU discharge, death or day 90, whichever occurs first

  5. Occurrence of any one of the following pre-specified potential complications

    Occurrence of any one of the following specified potential complications:

    venous thromboembolism arterial occlusion acute coronary syndrome acute respiratory distress syndrome

    Measured: Up to ICU discharge, death or day 90, whichever occurs first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2019
  2. Study start17 Aug 2021
  3. Primary completion17 Jul 2024
  4. Study completionNov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be allocated to either: cryopreserved or standard liquid-stored platelets
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03991481
Sponsor's protocol ID
ANZIC-RC/MR002
Acronym
CLIP II
Status last verified
Jan 2025
First submitted
9 May 2019
Last updated
3 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Reade MC, Marks DC, Howe BD, Bailey MJ, Bannon PG, Eastwood GM, French CJ, Gattas DJ, Higgins AM, Holley AD, Hu RT, Irving DO, Johnson L, McGuinness SP, McQuilten ZK, Royse AG, Smith JA, Weinberg L, Wood EM; Cryopreserved vs Liquid Platelets II (CLIP-II) Investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australasian Society of Car; Cryopreserved vs Liquid Platelets II (CLIP-II) Investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australasian Society of Cardiac and Thoracic Surgeons. Cryopreserved vs Liquid-Stored Platelets for the Treatment of Surgical Bleeding: The CLIP-II Randomized Noninferiority Clinical Trial. JAMA. 2026 Feb 17;335(7):600-608. doi: 10.1001/jama.2025.23355.

    PubMed 41360717

  • Reade MC, Marks DC, Howe B, McGuinness S, Parke R, Navarra L, Charlewood R, Johnson L, McQuilten Z; CLIP-II and CLIPNZ-II Investigators.; CLIP-II and CLIPNZ-II Investigators. Cryopreserved platelets compared with liquid-stored platelets for the treatment of surgical bleeding: protocol for two multicentre randomised controlled blinded non-inferiority trials (the CLIP-II and CLIPNZ-II trials). BMJ Open. 2022 Dec 20;12(12):e068933. doi: 10.1136/bmjopen-2022-068933.

    PubMed 36600425

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cryopreserved platelets and Liquid-stored platelets in people with Surgical Blood Loss and Hemorrhage, run by Australian and New Zealand Intensive Care Research Centre at 6 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volume of post-surgical bleeding in the first 24 hours (time frame: First 24 hours from the time of ICU admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03991481, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.

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