Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04912336 |
Other study ID # |
BC-07099 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 28, 2021 |
Est. completion date |
April 30, 2024 |
Study information
Verified date |
July 2023 |
Source |
University Hospital, Ghent |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
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).
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