Heart or lungfailure
Conditions
Interventions
Randomization between heparin administration with a target of 2-2.5 times
baseline aPTT (usual care, about 60-75 sec.), 1.5-2.0 times baseline aPTT
(45-60 sec.) or low molecular weight heparin (LMWH
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Adults treated with ECMO for heart or lungfailure
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed