Clinical trial NCT05959252: BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Extracorporeal Membrane Oxygenation Complication
Keywords: ECMO
Bivalirudin
Heparin
Extracorporeal membrane oxygenation
Lead sponsor: Sydney Local Health District
Sponsor class: OTHER_GOV
First posted: 2023-07-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Time in therapeutic range
timeFrame: 30 days
Secondary outcomes:
measure: Enrolment rate
timeFrame: 30 days
measure: Reasons for non-enrolment
timeFrame: 30 days
measure: Crossover between arms
timeFrame: 30 days
measure: Circuit changes
timeFrame: 30 days
measure: Daily mean aPTT and anti-Xa
timeFrame: 30 days
measure: Serious adverse events (SAEs)
timeFrame: 30 days
measure: Protocol violations
timeFrame: 30 days
measure: Thrombotic events
timeFrame: 30 days
measure: Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH)
timeFrame: 30 days
measure: Bleeding events defined by Bleeding Academic Research Consortium (BARC)
timeFrame: 30 days
measure: Survival to Intensive care Unit (ICU) discharge
timeFrame: 30 days
measure: Survival to hospital discharge
timeFrame: 30 days
measure: Blood product usage
timeFrame: 30 days
measure: Cost
timeFrame: 30 days
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
Study officials:
References: