Extracorporeal Life Support & Modification of Hemostasis

Status Active, not recruiting

Clinical Trial 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).

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04912336
Study type	Observational
Source	University Hospital, Ghent
Contact
Status	Active, not recruiting
Phase
Start date	May 28, 2021
Completion date	April 30, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Extracorporeal Life Support and Modification of Hemostasis — ELMOH

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms