Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05959252
Registration number
NCT05959252
Ethics application status
Date submitted
2/07/2023
Date registered
25/07/2023
Date last updated
13/08/2024
Titles & IDs
Public title
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
Query!
Scientific 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)
Query!
Secondary ID [1]
0
0
2023/ETH00443
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
BLUSH
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Extracorporeal Membrane Oxygenation Complication
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Unfractionated heparin
Treatment: Drugs - Bivalirudin
Active comparator: Bivalirudin - Bivalirudin protocol with target activated thromboplastin time (aPTT) of 50-70 seconds
Active comparator: Unfractionated Heparin - Unfractionated heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
Treatment: Drugs: Unfractionated heparin
Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
Treatment: Drugs: Bivalirudin
Bivalirudin protocol with target aPTT 50-70 seconds
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Time in therapeutic range
Query!
Assessment method [1]
0
0
Proportion of monitoring samples within therapeutic range
Query!
Timepoint [1]
0
0
30 days
Query!
Secondary outcome [1]
0
0
Enrolment rate
Query!
Assessment method [1]
0
0
Enrolment rate
Query!
Timepoint [1]
0
0
30 days
Query!
Secondary outcome [2]
0
0
Reasons for non-enrolment
Query!
Assessment method [2]
0
0
Reasons for non-enrolment of eligible patients into the study
Query!
Timepoint [2]
0
0
30 days
Query!
Secondary outcome [3]
0
0
Crossover between arms
Query!
Assessment method [3]
0
0
The number of cross over patients between arms of the study
Query!
Timepoint [3]
0
0
30 days
Query!
Secondary outcome [4]
0
0
Circuit changes
Query!
Assessment method [4]
0
0
The number of circuit changes and length of circuit life
Query!
Timepoint [4]
0
0
30 days
Query!
Secondary outcome [5]
0
0
Daily mean aPTT and anti-Xa
Query!
Assessment method [5]
0
0
Daily mean aPTT and anti-Xa versus stated range
Query!
Timepoint [5]
0
0
30 days
Query!
Secondary outcome [6]
0
0
Serious adverse events (SAEs)
Query!
Assessment method [6]
0
0
Number of SAEs
Query!
Timepoint [6]
0
0
30 days
Query!
Secondary outcome [7]
0
0
Protocol violations
Query!
Assessment method [7]
0
0
Number of protocol violations
Query!
Timepoint [7]
0
0
30 days
Query!
Secondary outcome [8]
0
0
Thrombotic events
Query!
Assessment method [8]
0
0
Number of deep vein thrombosis identified by ultrasound or CT
Query!
Timepoint [8]
0
0
30 days
Query!
Secondary outcome [9]
0
0
Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH)
Query!
Assessment method [9]
0
0
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)
Query!
Timepoint [9]
0
0
30 days
Query!
Secondary outcome [10]
0
0
Bleeding events defined by Bleeding Academic Research Consortium (BARC)
Query!
Assessment method [10]
0
0
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
Query!
Timepoint [10]
0
0
30 days
Query!
Secondary outcome [11]
0
0
Survival to Intensive care Unit (ICU) discharge
Query!
Assessment method [11]
0
0
Survival to discharge from ICU (percentage of patients surviving to ICU discharge)
Query!
Timepoint [11]
0
0
30 days
Query!
Secondary outcome [12]
0
0
Survival to hospital discharge
Query!
Assessment method [12]
0
0
Hospital Survival (percentage of patients surviving hospital discharge)
Query!
Timepoint [12]
0
0
30 days
Query!
Secondary outcome [13]
0
0
Blood product usage
Query!
Assessment method [13]
0
0
Total amount of red blood cells (RBC), platelets, plasma and blood products used during extracorporeal membrane oxygenation support
Query!
Timepoint [13]
0
0
30 days
Query!
Secondary outcome [14]
0
0
Cost
Query!
Assessment method [14]
0
0
Total cost of of extracorporeal membrane oxygenation support that includes blood products, blood tests and complications (measured in United States dollars)
Query!
Timepoint [14]
0
0
30 days
Query!
Eligibility
Key inclusion criteria
INCLUSION CRITERIA
* Patients receiving ECMO
* Age: 18 years or older
* Ability to randomise the patient within 4 hours of ECMO support initiation
EXCLUSION CRITERIA
* 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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/05/2026
Query!
Actual
Query!
Sample size
Target
80
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Sydney
Query!
Recruitment postcode(s) [1]
0
0
2050 - Sydney
Query!
Funding & Sponsors
Primary sponsor type
Government body
Query!
Name
Sydney Local Health District
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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. 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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05959252
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT05959252
Download to PDF