Other Clinical Trial - Bivalirudin vs Heparin in ECMO Patients

Status Withdrawn

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Extracorporeal Membrane Oxygenation Complication

Clinical Trial Details

NCT number	NCT03707418
Study type	Interventional
Source	Johns Hopkins University
Contact
Status	Withdrawn
Phase	Phase 1
Start date	April 2021
Completion date	June 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05486559` - The ECMO-Free Trial	N/A
Recruiting	`NCT04674657` - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Not yet recruiting	`NCT05306392` - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation	N/A
Terminated	`NCT02280460` - ECMO: Optimization of Its Use
Completed	`NCT02271126` - TEG Anticoagulation Monitoring During ECMO	Phase 1
Recruiting	`NCT05444764` - PREdiCtIon of Weanability, Survival and Functional outcomEs After ECLS
Completed	`NCT03659513` - The Effect of ECMO on the Pharmacokinetics of the Drugs and Their Clinical Efficacy
Not yet recruiting	`NCT06338345` - Pharmacokinetics and Modelling of Beta-Lactam in ECMO-VA Patients	N/A
Completed	`NCT05948332` - Definition and Management of Right Ventricular Injury in Adult Patients Receiving Extracorporeal Membrane Oxygenation
Recruiting	`NCT04273607` - Anticoagulation-free VV ECMO for Acute Respiratory Failure	Phase 2/Phase 3
Not yet recruiting	`NCT04956497` - Registry Study of Extracorporeal Cardiopulmonary Resuscitation (eCPR) in China
Completed	`NCT04052230` - Evolution of Diaphragm Thickness Under Veno-arterial ECMO
Terminated	`NCT04524585` - Partial Neuromuscular Blockade in Acute Respiratory Distress Syndrome	N/A
Completed	`NCT04620005` - Impact of Extra Corporal Membrane Oxygenation Services on Burnout Development in Intensive Care Units.
Recruiting	`NCT05721105` - Evaluation of Long-term Quality of Life in Children Supported With ExtraCorporeal Membrane Oxygenation (ECMO)
Recruiting	`NCT06095518` - DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study
Recruiting	`NCT03965208` - Safety and Efficacy of Bivalirudin Versus Heparin for Systemic Anticoagulation in Extracorporeal Membrane Oxygenation	Phase 4
Not yet recruiting	`NCT05814094` - Red Blood Cell Transfusion in ECMO - A Feasibility Trial	N/A
Not yet recruiting	`NCT06319677` - PK/PD Study of Anti-Infective Drugs in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation Treatment
Completed	`NCT05338593` - Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.