Extracorporeal Life Support and Modification of Hemostasis

Study Overview
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Brief Summary
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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
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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

Official Title
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Extra Corporeal Life Support and Modification of Hemostasis

Conditions
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Bleeding Disorder, Extra Corporeal Life Support, Thrombosis

Intervention / Treatment
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* Diagnostic Test: Standard coagulation profile
* Diagnostic Test: Specific coagulation tests
* Other: Bleeding Scores


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VV-ECMO<br>Patients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator. | Diagnostic Test: Standard coagulation profile<br>* prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount<br>Diagnostic Test: Specific coagulation tests<br>* AT III, anti Xa, ACT, ROTEM<br>Other: Bleeding Scores<br>* Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)<br>|
| VA-ECMO<br>Patients supported because of circulatory failure by Veno-Arterial Extra Corporeal Membrane Oxygenator. | Diagnostic Test: Standard coagulation profile<br>* prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount<br>Diagnostic Test: Specific coagulation tests<br>* AT III, anti Xa, ACT, ROTEM<br>Other: Bleeding Scores<br>* Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombocytopenia | Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria | incidence of clinical overt bleeding | 48 hours | 
| Clotting problems | Incidence of deep venous trombosis or emboli or ECMO circuit problems due to clotting | 48 hours | 
| Need for transfusion | Need for transfusion of packed red blood cells | 48 hours | 
| Change in visco-elastic testing | ROTEM changes | At 2 hours, 24 hours, 48 hours | 
| Survival | survival in the ICU, in the hospital, at day 28, day 90, 6months and 1 year | 1 year |