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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05959252




Registration number
NCT05959252
Ethics application status
Date submitted
2/07/2023
Date registered
25/07/2023
Date last updated
29/11/2023

Titles & IDs
Public title
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
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)
Secondary ID [1] 0 0
2023/ETH00443
Universal Trial Number (UTN)
Trial acronym
BLUSH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracorporeal Membrane Oxygenation Complication 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time in therapeutic range
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Enrolment rate
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Reasons for non-enrolment
Timepoint [2] 0 0
30 days
Secondary outcome [3] 0 0
Crossover between arms
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Circuit changes
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Daily mean aPTT and anti-Xa
Timepoint [5] 0 0
30 days
Secondary outcome [6] 0 0
Serious adverse events (SAEs)
Timepoint [6] 0 0
30 days
Secondary outcome [7] 0 0
Protocol violations
Timepoint [7] 0 0
30 days
Secondary outcome [8] 0 0
Thrombotic events
Timepoint [8] 0 0
30 days
Secondary outcome [9] 0 0
Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH)
Timepoint [9] 0 0
30 days
Secondary outcome [10] 0 0
Bleeding events defined by Bleeding Academic Research Consortium (BARC)
Timepoint [10] 0 0
30 days
Secondary outcome [11] 0 0
Survival to Intensive care Unit (ICU) discharge
Timepoint [11] 0 0
30 days
Secondary outcome [12] 0 0
Survival to hospital discharge
Timepoint [12] 0 0
30 days
Secondary outcome [13] 0 0
Blood product usage
Timepoint [13] 0 0
30 days
Secondary outcome [14] 0 0
Cost
Timepoint [14] 0 0
30 days

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05959252
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05959252