BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

Extracorporeal Membrane Oxygenation Complication Clinical Trial

— BLUSH  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05959252
• Other study ID #: 2023/ETH00443
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2024
• Est. completion date: May 1, 2026

Study information

• Verified date: July 2023
• Source: Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication

Intervention

Drug:
• Unfractionated heparin
Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
• Bivalirudin
Bivalirudin protocol with target aPTT 50-70 seconds

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in therapeutic range	Proportion of monitoring samples within therapeutic range	30 days
Secondary	Enrolment rate	Enrolment rate	30 days
Secondary	Reasons for non-enrolment	Reasons for non-enrolment of eligible patients into the study	30 days
Secondary	Crossover between arms	The number of cross over patients between arms of the study	30 days
Secondary	Circuit changes	The number of circuit changes and length of circuit life	30 days
Secondary	Daily mean aPTT and anti-Xa	Daily mean aPTT and anti-Xa versus stated range	30 days
Secondary	Serious adverse events (SAEs)	Number of SAEs	30 days
Secondary	Protocol violations	Number of protocol violations	30 days
Secondary	Thrombotic events	Number of deep vein thrombosis identified by ultrasound or CT	30 days
Secondary	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)	30 days
Secondary	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 UFH Type 2: Bleeding requiring transfusion of PRBC and reduction of UFH Type 3: Life-threatening bleeding requiring, transfusion of PRBC, surgical intervention or discontinuation of ECMO Type 4: Any fatal bleeding	30 days
Secondary	Survival to Intensive care Unit (ICU) discharge	Survival to discharge from ICU (percentage of patients surviving to ICU discharge)	30 days
Secondary	Survival to hospital discharge	Hospital Survival (percentage of patients surviving hospital discharge)	30 days
Secondary	Blood product usage	Total amount of red blood cells (RBC), platelets, plasma and blood products used during extracorporeal membrane oxygenation support	30 days
Secondary	Cost	Total cost of of extracorporeal membrane oxygenation support that includes blood products, blood tests and complications (measured in United States dollars)	30 days