Extracorporeal Membrane Oxygenation Complication Clinical Trial
Official title:
BivaLirudin versUS Heparin in ECMO - A Registry-embedded, Randomised, Open Label, Feasibility Trial Comparing Two Anticoagulation Strategies in Patients on Extracorporeal Membrane Oxygenation (ECMO)
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. ;
| 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.
|