Verslagen

Samenvatting van de aanvraag

Samenvatting
Dit item is dichtgeklapt
Dit item is opengeklapt

OBJECTIVE

ECLS treatment has a mortality of 38%, for a large part treatment related due to complications. The most feared complication is ischemic stroke for which heparin is administered with an aPTT target 2.0-2.5 times baseline (approximately 60-75 sec). However, there is no relation between aPTT and the occurrence of stroke (1.2%), but there is a relation with the much more frequent occurrence of bleeding complications (55%) and blood transfusion. Both are strongly related to outcome. Our objective is to study if reduced anticoagulation targets diminish bleeding complications without an increase in thromboembolic complications or a negative impact on outcome.

 

STUDY DESIGN

Three-arm non-inferiority RCT in all Dutch patients with ECLS treatment (and informed consent)

 

USUAL CARE /COMPARISON

Randomization between a target of 2-2.5 times baseline aPTT (usual care, about 60-75 sec.), 1.5-2.0 times (45-60 sec.) and LMWH guided by weight and renal function.

 

OUTCOME MEASURES

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, or acute pump failure; 3) mortality at 6 months.

Secondary outcome parameters are: 1) blood transfusions; 2) quality of life (HR-QoL) at 6 months; 3) exchange of the membrane oxygenator (ECMO); 4) vessel thrombosis after ECLS removal detected by echography; 5) costs; and 6) the individual components of the composite outcome.

 

SAMPLE SIZE CALCULATION/DATA ANALYSIS

We estimate that with an aPTT target of 40-60 sec. or with use of LMWH the primary endpoint will be met in 60% of patients compared to 70% with usual care. To show non-inferiority 91 patients per group are needed. To compensate for a lower effect and drop-outs 330 patients will be enrolled. Results will be analyzed by intention to treat.

 

TIME SCHEDULE

30 months

 

Naar boven
Direct naar: InhoudDirect naar: NavigatieDirect naar: Onderkant website