Thrombosis Clinical Trial
Official title:
Extra Corporeal Life Support and Modification of Hemostasis
To evaluate change in coagulation tests during a 48-h period after initiation VV-ECMO and VA-ECMO. (ECMO= Extra Corporeal Membrane Oxygenator) Assessment of bleeding during Veno-Venous Extracoporeal Membrane Oxygenator (VV-ECMO) and Veno-Arterial Extracoporeal Membrane Oxygenator (VA-ECMO).
This is a multi-center, prospective, pilot cohort study, performed in the Intensive Care Units (ICUs) of the Ghent University Hospital, CHU Liège, University Hospital Brussels, and University Hospital Munster. Each group will contain 20 subjects; in total there will be 40 subjects 2 groups of 20 patients GROUP 1: VV-ECMO n = 20 GROUP 2: VA-ECMO n = 20 - Demographics: age, sex, comorbidities, medication, reason for ECMO therapy - Simplified Acute Physiology Score (SAPS) 3 at time of ICU admission. - Components of the Sequential Organ Failure Assessment score daily (based on worst value of each component of the score) - ECMO characteristics (place of cannulation, type of cannulas, oxygenator, bloodflow, gasflow and pressure registrations) - Incidence and severity of bleeding, scored according to the GUSTO and BARC scores - Coagulation profile: At inclusion (before heparine infusion is started), 2h after start of therapy, 24h, and 48h, and at specific moments of clinical suspicion of profound altered hemostasis. We defined a coagulation profile as a set of tests that includes - prothrombin time (PT), international normalized ratio (INR) - activated partial thromboplastin time (aPTT) and heparin ratio - the fibrinogen level - platelets - ACT (iACT®, …) - D-dimer - ROTEM (extem, intem, heptem) or TEG (Utrecht) - AT III - anti Xa - Temperature daily (H/L) (core) - Patient characteristics that may influence coagulation or the results of coagulation tests: body weight, Body Mass Index, drugs, C-reactive protein (as a marker for inflammation), Hemoglobin level, LDH, unconjugated bilirubin, (or haptoglobine or plasma free haemoglobin, if tested) - Heparin dose ;
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