HEPARIN for Extracorporeal membrane oxygenation (ECMO) support

Inclusion criteria

• {"criterion_text":"- All adults receiving ECMO treatment at the ICU of one of the participating centers during the study period are eligible for inclusion."}

Exclusion criteria

• {"criterion_text":"- The exclusion criteria are as follows: (1) patients in whom the ECMO is only used to bridge a procedure like a high-risk percutaneous coronary intervention or during surgery; (2) no (deferred) informed consent; (3) vital indication for robust anticoagulation (e.g., mechanic mitral valve, pulmonary embolism, a clot in the cardiac ventricle); and (4) a history of heparin-induced thrombocytopenia (HIT)."}

Primary endpoints

• {"endpoint_text":"- The primary outcome parameter is a combined endpoint consisting of: 1) major bleeding including hemorrhagic stroke according to the ELSO definitions; 2) severe thromboembolic complication defined as ischemic stroke, limb ischemia (not related with distal perfusion catheter), or acute pump failure with emergency exchange; 3) mortality at 6 months.","definition_or_measurement_approach":"Major bleeding: according to the ELSO definitions; Severe thromboembolic complication: defined as ischemic stroke, limb ischemia (not related with distal perfusion catheter), or acute pump failure with emergency exchange; Mortality: mortality at 6 months."}

Secondary endpoints

• {"endpoint_text":"- Secondary outcome parameters are: 1) blood transfusions; 2) health related quality of life (HR-QoL) at 6 months; 3) exchange of the membrane oxygenator; 4) vessel thrombosis after ECMO removal detected by echography; 5) pulmonary embolism; 6) costs; 7) the individual components of the composite outcome; and 8) all thromboembolic complications combined.","definition_or_measurement_approach":"Secondary outcomes as listed: blood transfusions; HR-QoL at 6 months; exchange of the membrane oxygenator; vessel thrombosis after ECMO removal detected by echography; pulmonary embolism; costs; the individual components of the composite outcome; all thromboembolic complications combined."}

Methods

• Recruitment of adults receiving ECMO at participating intensive care units in the Netherlands; inclusion based on (deferred) informed consent obtained from patients; no other recruitment channels described in the record.

Netherlands

Earliest CTIS Part Ii Submission Date

27-01-2025

Latest Decision Or Authorization Date

28-01-2025

Processing Time Days

1

Number Of Sites

7

Number Of Participants

330

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands