Extracorporeal Life Support and Modification of Hemostasis

Thrombosis Clinical Trial

— ELMOH  

Official title:

Extra Corporeal Life Support and Modification of Hemostasis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04912336
• Other study ID #: BC-07099
• Status: Active, not recruiting
• 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
• 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: April 30, 2024
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Hemostatic Disorders
• Thrombosis

Intervention

Diagnostic Test:
• Standard coagulation profile
prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount
• Specific coagulation tests
AT III, anti Xa, ACT, ROTEM

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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent
Belgium	University Hospital Brussels	Jette
Belgium	Centre Hospitalier Universitaire Liege	Liège
Belgium	CHU Charleroi	Lodelinsart	Henegouwen
Belgium	CHU UCL Namur- Godinne	Yvoir	Namen
Germany	University Hospital Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombocytopenia	Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients	48 hours
Secondary	Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria	incidence of clinical overt bleeding	48 hours
Secondary	Clotting problems	Incidence of deep venous trombosis or emboli or ECMO circuit problems due to clotting	48 hours
Secondary	Need for transfusion	Need for transfusion of packed red blood cells	48 hours
Secondary	Change in visco-elastic testing	ROTEM changes	At 2 hours, 24 hours, 48 hours
Secondary	Survival	survival in the ICU, in the hospital, at day 28, day 90, 6months and 1 year	1 year