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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Unfractionated Heparin protocol with target anti-Xa of 0.3-0.5 IU/mL
Bivalirudin protocol with target aPTT 50-70 seconds
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
RECRUITINGTime in therapeutic range
Proportion of monitoring samples within therapeutic range
Time frame: 30 days
Enrolment rate
Enrolment rate
Time frame: 30 days
Reasons for non-enrolment
Reasons for non-enrolment of eligible patients into the study
Time frame: 30 days
Crossover between arms
The number of cross over patients between arms of the study
Time frame: 30 days
Circuit changes
The number of circuit changes and length of circuit life
Time frame: 30 days
Daily mean aPTT and anti-Xa
Daily mean aPTT and anti-Xa versus stated range
Time frame: 30 days
Serious adverse events (SAEs)
Number of SAEs
Time frame: 30 days
Protocol violations
Number of protocol violations
Time frame: 30 days
Thrombotic events
Number of deep vein thrombosis identified by ultrasound or CT
Time frame: 30 days
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)
Time frame: 30 days
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 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
Time frame: 30 days
Survival to Intensive care Unit (ICU) discharge
Survival to discharge from ICU (percentage of patients surviving to ICU discharge)
Time frame: 30 days
Survival to hospital discharge
Hospital Survival (percentage of patients surviving hospital discharge)
Time frame: 30 days
Blood product usage
Total amount of red blood cells (RBC), platelets, plasma and blood products used during extracorporeal membrane oxygenation support
Time frame: 30 days
Cost
Total cost of of extracorporeal membrane oxygenation support that includes blood products, blood tests and complications (measured in United States dollars)
Time frame: 30 days
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