A Randomized Study Comparing Bivalirudin vs Heparin in Patients With Extracorporeal Membrane Oxygenator (ECMO) Support

NCT03707418 Phase 1 WITHDRAWN

This is an open label, randomized study comparing the clinical outcomes of unfractionated Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.

Details

Lead sponsor	Johns Hopkins University
Phase	Phase 1
Status	WITHDRAWN
Start date	2021-04
Completion	2021-06

Conditions

• Extracorporeal Membrane Oxygenation Complication

Interventions

• Heparin Sodium
• Bivalirudin Injection [Angiomax]

Primary outcomes

• Number of heparin-induced thrombocytopenia (HIT) events — 30 days
  This will be assessed by serum platelet factor 4 antibody level
• Number of Cross-overs between arms — 30 days
  This will be assessed by number of cross over of patients from one arm to the other anti-coagulation arm for any particular clinical reason. Crossover patients will remain in the study and we will continue to collect protocol driven data. These patients will be analyzed separately from those with no cross-over.
• Number of circuit failures requiring a circuit exchange — 30 days
  Will be determined by total number of circuit exchanges needed in ECMO circuit due to thrombosis. Circuit exchanges may be done due to lack of adequate gas exchange or increased resistance pre and post oxygenator \>50mmHg, circuit thrombosis or failure requiring emergent decannulation
• Thrombotic events — 30 days
  Collect number of thrombotic events, defined as any of the following events; embolic strokes, embolic end-organ ischemia, embolic ischemia to limbs, deep vein thrombosis or venous thromboembolism, Oxygenator effectiveness measured by resistance, Alveolar-arterial oxygen gradient and carbon dioxide elimination
• Bleeding events — 30 days
  Will be assessed by the total number of one or more of the following: Chest tube output of blood, number of take-backs to operating room for bleeding, number of Hemorrhagic strokes, Gastrointestinal bleeding, Retroperitoneal hemorrhage, number of cessations of anticoagulation for refractory bleeding and any use of antifibrinolytics or factor VII
• Renal failure — 30 days
  Defined as initiation of renal replacement therapy for kidney injury that develops on ECMO or increase in serum creatinine by more than 2 times its baseline or decrease in Glomerular Filtration Rate by more than 50% or urine output less than 0.3 mL/kg/hr. We will determine the number of patients with renal failure

Countries

United States