NCT04912336

Extracorporeal Life Support and Modification of Hemostasis

Extra Corporeal Life Support and Modification of Hemostasis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bleeding Disorder
• Extra Corporeal Life Support
• Thrombosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Standard coagulation profile	prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount
DIAGNOSTIC_TEST	Specific coagulation tests	AT III, anti Xa, ACT, ROTEM
OTHER	Bleeding Scores	Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)

Timeline

• Start date: 2021-05-28
• Primary completion: 2023-01-16
• Completion: 2024-04-30
• First posted: 2021-06-03
• Last updated: 2024-07-30

Locations

6 sites across 2 countries: Belgium, Germany