Bivalirudin vs Heparin in ECMO Patients

Extracorporeal Membrane Oxygenation Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03707418
• Other study ID #: IRB00176475
• Status: Withdrawn
• Phase: Phase 1
• Start date: April 2021
• Est. completion date: June 2021

Study information

• Verified date: April 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Extracorporeal Membrane Oxygenation Complication

Intervention

Drug:
• Heparin Sodium
Intravenous Heparin titrated to Partial ThromboplastinTime (PTT) levels
• Bivalirudin Injection [Angiomax]
Intravenous Bivalirudin titrated to Activated Clotting Time (ACT) levels

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of heparin-induced thrombocytopenia (HIT) events	This will be assessed by serum platelet factor 4 antibody level	30 days
Primary	Number of Cross-overs between arms	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.	30 days
Primary	Number of circuit failures requiring a circuit exchange	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	30 days
Primary	Thrombotic events	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	30 days
Primary	Bleeding events	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	30 days
Primary	Renal failure	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	30 days
Primary	Number of Transfusions	This will be assessed by any of the following: number of utilizations of packed red blood cells and utilization of fresh frozen plasma, utilization of platelets, utilization of cryoprecipitate, utilization of anti-thrombin III, utilization of factor VII, utilization of prothrombin complex concentrate	30 days
Primary	Number of emergent decannulations	This will be assessed by the number of times patient is separated from ECMO	30 days
Primary	Number of patients surviving to discharge	This will be assessed by the number of patients in each arm who survive to discharge	30 days