Bivalirudin vs Heparin in ECMO Patients
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | June 30, 2019 |
| End Date: | December 31, 2020 |
| Contact: | Judi Willhide, RN |
| Email: | jwillhi3@jhmi.edu |
| Phone: | 410-955-3597 |
A Randomized Study Comparing Bivalirudin vs Heparin in Patients With Extracorporeal Membrane Oxygenator (ECMO) Support
This is an open label, randomized study comparing the clinical outcomes of unfractionated
Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.
Heparin and Bivalirudin for anticoagulation in adult subjects requiring ECMO support.
This open label randomized study will compare the clinical outcomes of patients on ECMO who
are anticoagulated with Heparin and Bivalirudin. Patients will be anticoagulated with a
heparin bolus at the commencement of ECMO per standard of care, as there will be insufficient
time to randomize these frequently emergent patients. Consent for the study will be obtained
from a legally authorized representative Prior to starting a continuous infusion of
maintenance anticoagulation, patients will be randomized to bivalirudin or heparin. Outcome
measures are bleeding, thrombosis, development of Heparin Induced thrombocytopenia, number of
cross-overs between the two research arms, circuit failures, decannulation, deaths and
discharges from hospital.
are anticoagulated with Heparin and Bivalirudin. Patients will be anticoagulated with a
heparin bolus at the commencement of ECMO per standard of care, as there will be insufficient
time to randomize these frequently emergent patients. Consent for the study will be obtained
from a legally authorized representative Prior to starting a continuous infusion of
maintenance anticoagulation, patients will be randomized to bivalirudin or heparin. Outcome
measures are bleeding, thrombosis, development of Heparin Induced thrombocytopenia, number of
cross-overs between the two research arms, circuit failures, decannulation, deaths and
discharges from hospital.
Inclusion Criteria:
- Adult patients on veno-arterial (VA) or veno-venous (VV)ECMO
Exclusion Criteria:
- Patient or surrogate decision makers cannot provide informed consent.
- Patients who have intolerance to either heparin or bivalirudin
- Patients who received any form of thrombolytic therapy within the past 30 days.
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