Clinical trial NCT04912336: Extracorporeal Life Support and Modification of Hemostasis
Official title: Extra Corporeal Life Support and Modification of Hemostasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bleeding Disorder
Extra Corporeal Life Support
Thrombosis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 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

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Thrombocytopenia
timeFrame: 48 hours
Secondary outcomes:
measure: Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria
timeFrame: 48 hours
measure: Clotting problems
timeFrame: 48 hours
measure: Need for transfusion
timeFrame: 48 hours
measure: Change in visco-elastic testing
timeFrame: At 2 hours, 24 hours, 48 hours
measure: Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Lodelinsart
country: Belgium
facility: CHU Charleroi
state: Henegouwen
city: Yvoir
country: Belgium
facility: CHU UCL Namur- Godinne
state: Namen
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Jette
country: Belgium
facility: University Hospital Brussels
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire Liege
city: Münster
country: Germany
facility: University Hospital Münster
Study officials:
affiliation: University Hospital, Ghent
name: Harlinde Peperstraete, MD
role: PRINCIPAL_INVESTIGATOR
References: