Extracorporeal Membrane Oxygenation ComplicationPhase 2BLUSHNCT05959252
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
A Phase 2 study testing Unfractionated heparin and Bivalirudin in people with Extracorporeal Membrane Oxygenation Complication, run by Sydney Local Health District at 1 site in Australia.
Trial summary
The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- Unfractionated heparin and Bivalirudin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustralia
- Study dates
- 1 May 2024to 1 Sep 2026
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving ECMO
- Age: 18 years or older
- Ability to randomise the patient within 4 hours of ECMO support initiation
Who cannot join
- Post-cardiotomy ECMO patients
- Contraindication to heparin or bivalirudin at time of randomisation e.g., active bleeding
- Heparin induced thrombotic thrombocytopenia syndrome
- Where the patient is expected to be disconnected from ECMO in the next day after cannulation.
- Limitations of care put in place either through patient wishes or the treating medical teams
- Other reason where the treating physician deems the study is not in the patient's best interest
- Patients who are suspected or confirmed to be pregnant
- Inherited bleeding or thrombotic disorders, Systemic Lupus Erythematosus patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
Timothy J Southwood, +61295156111, timothy.southwood@health.nsw.gov.au
Mark Dennis, PhD, +61295156111, mark.dennis@sydney.edu.au
About this study
Official title: BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)
The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support.
The main question it aims to answer are include the ability to maintain anticoagulation within defined therapeutic range, bleeding and thrombotic complications and a comparison of the total cost of anticoagulation care.
Participants will be randomised to either anticoagulation with Bivalirudin or anticoagulation with Unfractionated Heparin.
Read the detailed description
Rationale:
Anticoagulation whilst on extracorporeal membrane oxygenation (ECMO) is required. Bleeding and thrombotic complications whilst on ECMO are common and may effect the patient outcome. The optimal anticoagulant for ECMO patients is not clear and there exists no randomised control trial data comparing anticoagulants on ECMO. This Phase 2b trial will provide data to enable larger definitive phase III trials to determine the best anticoagulant whilst on ECMO.
Hypothesis: Hypothesis: In adults ECMO patients'; anticoagulation with Bivalirudin results in more samples within therapeutic range than unfractionated Heparin. Total anticoagulation costs with Bivalirudin are similar to unfractionated Heparin.
The objectives of this study is to assess anticoagulation protocol of bivalirudin versus unfractionated heparin and assess the to the cost of each protocol.
- Being tested
- Unfractionated heparin, Bivalirudin
- Keywords
- ECMO, Bivalirudin, Heparin, Extracorporeal membrane oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated heparinDrug
Also called Heparin
Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
BivalirudinDrug
Bivalirudin protocol with target aPTT 50-70 seconds
| Study group | Role | What they receive |
|---|---|---|
| Bivalirudin | Active comparator | Bivalirudin protocol with target activated thromboplastin time (aPTT) of 50-70 seconds Receives: Drug: Bivalirudin |
| Unfractionated Heparin | Active comparator | Unfractionated heparin protocol with target anti-Xa of 0.3-0.5 IU/mL Receives: Drug: Unfractionated heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in therapeutic range
Proportion of monitoring samples within therapeutic range
Measured: 30 days
Secondary outcomes (14)
Enrolment rate
Enrolment rate
Measured: 30 days
Reasons for non-enrolment
Reasons for non-enrolment of eligible patients into the study
Measured: 30 days
Crossover between arms
The number of cross over patients between arms of the study
Measured: 30 days
Circuit changes
The number of circuit changes and length of circuit life
Measured: 30 days
Daily mean aPTT and anti-Xa
Daily mean aPTT and anti-Xa versus stated range
Measured: 30 days
Serious adverse events (SAEs)
Number of SAEs
Measured: 30 days
Protocol violations
Number of protocol violations
Measured: 30 days
Thrombotic events
Number of deep vein thrombosis identified by ultrasound or CT
Measured: 30 days
Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH)
Major bleeding was defined according to the criteria as clinically overt bleeding which was fatal or associated with any of the following: (a) a fall in hemoglobin level of 2 g/dL or more or documented transfusion of at least 2 units of packed red blood cells, (b) involvement of a critical anatomical site (intracranial, spinal, ocular, pericardial, articular, intramuscular with compartment syndrome, retroperitoneal)
Measured: 30 days
Bleeding events defined by Bleeding Academic Research Consortium (BARC)
Number of bleeding events as per BARC
Hemorrhagic complications assessed and adapted as per Bleeding Academic Research Consortium (BARC) Type 0: No bleeding Type 1: Bleeding requiring transfusion of packed red blood cells (PRBC) or reduction of unfractionated heparin Type 2: Bleeding requiring transfusion of PRBC and reduction of unfractionated heparin Type 3: Life-threatening bleeding requiring, transfusion of PRBC, surgical intervention or discontinuation of ECMO Type 4: Any fatal bleeding
Measured: 30 days
Survival to Intensive care Unit (ICU) discharge
Survival to discharge from ICU (percentage of patients surviving to ICU discharge)
Measured: 30 days
Survival to hospital discharge
Hospital Survival (percentage of patients surviving hospital discharge)
Measured: 30 days
Blood product usage
Total amount of red blood cells (RBC), platelets, plasma and blood products used during extracorporeal membrane oxygenation support
Measured: 30 days
Cost
Total cost of of extracorporeal membrane oxygenation support that includes blood products, blood tests and complications (measured in United States dollars)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 May 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sydney Local Health District
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959252
- Sponsor's protocol ID
- 2023/ETH00443
- Acronym
- BLUSH
- Status last verified
- May 2026
- First submitted
- 2 Jul 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT05959252
- Acronym / sponsor ID
- BLUSH / 2023/ETH00443
- Keywords
- ECMO, Bivalirudin, Heparin, Extracorporeal membrane oxygenation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sydney Local Health DistrictOther government
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support.
The main question it aims to answer are include the ability to maintain anticoagulation within defined therapeutic range, bleeding and thrombotic complications and a comparison of the total cost of anticoagulation care.
Participants will be randomised to either anticoagulation with Bivalirudin or anticoagulation with Unfractionated Heparin.
Detailed description
Rationale:
Anticoagulation whilst on extracorporeal membrane oxygenation (ECMO) is required. Bleeding and thrombotic complications whilst on ECMO are common and may effect the patient outcome. The optimal anticoagulant for ECMO patients is not clear and there exists no randomised control trial data comparing anticoagulants on ECMO. This Phase 2b trial will provide data to enable larger definitive phase III trials to determine the best anticoagulant whilst on ECMO.
Hypothesis: Hypothesis: In adults ECMO patients'; anticoagulation with Bivalirudin results in more samples within therapeutic range than unfractionated Heparin. Total anticoagulation costs with Bivalirudin are similar to unfractionated Heparin.
The objectives of this study is to assess anticoagulation protocol of bivalirudin versus unfractionated heparin and assess the to the cost of each protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bivalirudin | Active comparator | Drug: BivalirudinBivalirudin protocol with target activated thromboplastin time (aPTT) of 50-70 seconds |
| Unfractionated Heparin | Active comparator | Drug: Unfractionated heparinUnfractionated heparin protocol with target anti-Xa of 0.3-0.5 IU/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving ECMO
- Age: 18 years or older
- Ability to randomise the patient within 4 hours of ECMO support initiation
Key exclusion criteria (8 listed)
- Post-cardiotomy ECMO patients
- Contraindication to heparin or bivalirudin at time of randomisation e.g., active bleeding
- Heparin induced thrombotic thrombocytopenia syndrome
- Where the patient is expected to be disconnected from ECMO in the next day after cannulation.
- Limitations of care put in place either through patient wishes or the treating medical teams
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfractionated heparinAlso: HeparinUnfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL | Drug | Unfractionated Heparin |
| BivalirudinBivalirudin protocol with target aPTT 50-70 seconds | Drug | Bivalirudin |
Primary outcome
Time in therapeutic range
Time frame: 30 days
Proportion of monitoring samples within therapeutic range
14 secondary outcomes
Enrolment rate
Time frame: 30 days
Reasons for non-enrolment
Time frame: 30 days
Crossover between arms
Time frame: 30 days
Circuit changes
Time frame: 30 days
Daily mean aPTT and anti-Xa
Time frame: 30 days
Serious adverse events (SAEs)
Time frame: 30 days
Protocol violations
Time frame: 30 days
Thrombotic events
Time frame: 30 days
Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH)
Time frame: 30 days
Bleeding events defined by Bleeding Academic Research Consortium (BARC)
Time frame: 30 days
Survival to Intensive care Unit (ICU) discharge
Time frame: 30 days
Survival to hospital discharge
Time frame: 30 days
Blood product usage
Time frame: 30 days
Cost
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Unfractionated heparin and Bivalirudin in people with Extracorporeal Membrane Oxygenation Complication, run by Sydney Local Health District at 1 site 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in therapeutic range (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.