BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation
- Conditions
- Extracorporeal Membrane Oxygenation Complication
- Interventions
- Registration Number
- NCT05959252
- Lead Sponsor
- Sydney Local Health District
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unfractionated Heparin Unfractionated heparin Unfractionated heparin protocol with target anti-Xa of 0.3-0.5 IU/mL Bivalirudin Bivalirudin Bivalirudin protocol with target activated thromboplastin time (aPTT) of 50-70 seconds
- Primary Outcome Measures
Name Time Method Time in therapeutic range 30 days Proportion of monitoring samples within therapeutic range
- Secondary Outcome Measures
Name Time Method Serious adverse events (SAEs) 30 days Number of SAEs
Reasons for non-enrolment 30 days Reasons for non-enrolment of eligible patients into the study
Crossover between arms 30 days The number of cross over patients between arms of the study
Daily mean aPTT and anti-Xa 30 days Daily mean aPTT and anti-Xa versus stated range
Enrolment rate 30 days Enrolment rate
Protocol violations 30 days Number of protocol violations
Circuit changes 30 days The number of circuit changes and length of circuit life
Thrombotic events 30 days Number of deep vein thrombosis identified by ultrasound or CT
Bleeding events defined by Bleeding Academic Research Consortium (BARC) 30 days 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 bleedingSurvival to Intensive care Unit (ICU) discharge 30 days Survival to discharge from ICU (percentage of patients surviving to ICU discharge)
Survival to hospital discharge 30 days Hospital Survival (percentage of patients surviving hospital discharge)
Blood product usage 30 days Total amount of red blood cells (RBC), platelets, plasma and blood products used during extracorporeal membrane oxygenation support
Major bleeding events defined by International Society of Thrombosis and Haemostasis (ISTH) 30 days 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)
Cost 30 days Total cost of of extracorporeal membrane oxygenation support that includes blood products, blood tests and complications (measured in United States dollars)
Trial Locations
- Locations (1)
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia