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NCT Number: NCT04912336

Extracorporeal Life Support and Modification of Hemostasis

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).

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Key information

Conditions

Bleeding Disorder Cardiovascular Diseases Embolism and Thrombosis Extra Corporeal Life Support Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Charleroi, Lodelinsart, Henegouwen, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard coagulation profile

Diagnostic Test

prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount

Specific coagulation tests

Diagnostic Test

AT III, anti Xa, ACT, ROTEM

Bleeding Scores

Other

Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)

Primary outcomes

  1. Thrombocytopenia

    Time frame: 48 hours

    Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients

Secondary outcomes

  1. Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria

    Time frame: 48 hours

    incidence of clinical overt bleeding

  2. Clotting problems

    Time frame: 48 hours

    Incidence of deep venous trombosis or emboli or ECMO circuit problems due to clotting

  3. Need for transfusion

    Time frame: 48 hours

    Need for transfusion of packed red blood cells

  4. Change in visco-elastic testing

    Time frame: At 2 hours, 24 hours, 48 hours

    ROTEM changes

  5. Survival

    Time frame: 1 year

    survival in the ICU, in the hospital, at day 28, day 90, 6months and 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Extra Corporeal Life Support and Modification of Hemostasis

Acronym: ELMOH

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 3, 2021
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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