Extracorporeal Life Support and Modification of Hemostasis (ELMOH)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Extra Corporeal Life Support; Thrombosis; Bleeding Disorder

Treatments: Other: Bleeding Scores; Diagnostic Test: Specific coagulation tests; Diagnostic Test: Standard coagulation profile

Study type: Observational

Funder types: Other

Identifiers

NCT04912336

BC-07099

Details and patient eligibility

About

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).

Full 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

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

43 participants in 2 patient groups

VV-ECMO

Description:

Patients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator.

Treatment:

Diagnostic Test: Standard coagulation profile

Diagnostic Test: Specific coagulation tests

Other: Bleeding Scores

VA-ECMO

Description:

Patients supported because of circulatory failure by Veno-Arterial Extra Corporeal Membrane Oxygenator.

Treatment:

Diagnostic Test: Standard coagulation profile

Diagnostic Test: Specific coagulation tests

Other: Bleeding Scores