Reduced Anticoagulation Targets in Extracorporeal life support

Phase 3

Recruiting

• Conditions: Heart or lungfailure; 10019280; 10024970

• Registration Number: NL-OMON50046
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

Adults treated with ECMO for heart or lungfailure

Exclusion Criteria

• Patients in whom the ECMO is only used to bridge a procedure like a high risk
percutaneous coronary intervention or during surgery
• Vital indication for robust anticoagulation (e.g. mechanic mitral valve,
pulmonary embolism, clot in cardiac ventricle)
• History of heparin induced thrombocytopenia (HIT)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter is a combined endpoint consisting of: 1) major<br /><br>bleeding including hemorrhagic stroke according to the ELSO definitions; 2)<br /><br>severe thromboembolic complication defined as ischemic stroke, limb ischemia<br /><br>(not related with distal perfusion catheter), or acute pump failure with<br /><br>emergency exchange; 3) mortality at 6 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters are: 1) blood transfusions; 2) health related<br /><br>quality of life (HR-QoL) at 6 months; 3) exchange of the membrane oxygenator;<br /><br>4) vessel thrombosis after ECMO removal detected by echography; 5) pulmonary<br /><br>embolism; 6) costs; 7) the individual components of the composite outcome; and<br /><br>8) all thromboembolic complications combined.</p><br>