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
Study Type
OBSERVATIONAL
Enrollment
43
prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount
AT III, anti Xa, ACT, ROTEM
Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)
CHU Charleroi
Lodelinsart, Henegouwen, Belgium
CHU UCL Namur- Godinne
Yvoir, Namen, Belgium
Ghent University Hospital
Ghent, Belgium
University Hospital Brussels
Jette, Belgium
Thrombocytopenia
Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients
Time frame: 48 hours
Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria
incidence of clinical overt bleeding
Time frame: 48 hours
Clotting problems
Incidence of deep venous trombosis or emboli or ECMO circuit problems due to clotting
Time frame: 48 hours
Need for transfusion
Need for transfusion of packed red blood cells
Time frame: 48 hours
Change in visco-elastic testing
ROTEM changes
Time frame: At 2 hours, 24 hours, 48 hours
Survival
survival in the ICU, in the hospital, at day 28, day 90, 6months and 1 year
Time frame: 1 year
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Centre Hospitalier Universitaire Liege
Liège, Belgium
University Hospital Münster
Münster, Germany