Bleeding Disorder, Extra Corporeal Life Support, Thrombosis
Conditions
Brief summary
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).
Detailed description
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
Interventions
DIAGNOSTIC_TESTStandard coagulation profile
prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount
DIAGNOSTIC_TESTSpecific coagulation tests
AT III, anti Xa, ACT, ROTEM
OTHERBleeding Scores
Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)
Sponsors
University Hospital, Ghent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* GROUP 1: patients who will be initiated on VV-ECMO within a 12-h period * GROUP 2: patients who will be initiated on VA-ECMO within a 12-h period * ≥ 18 years * Signed Informed Consent, signed by subject or authorized representative
Exclusion criteria
Expected survival \<48-h Known coagulopathy Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombocytopenia | 48 hours | Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria | 48 hours | incidence of clinical overt bleeding |
| Clotting problems | 48 hours | Incidence of deep venous trombosis or emboli or ECMO circuit problems due to clotting |
| Need for transfusion | 48 hours | Need for transfusion of packed red blood cells |
| Change in visco-elastic testing | At 2 hours, 24 hours, 48 hours | ROTEM changes |
| Survival | 1 year | survival in the ICU, in the hospital, at day 28, day 90, 6months and 1 year |
Countries
Belgium, Germany
Outcome results
None listed