Extracorporeal Life Support and Modification of Hemostasis

Completed

• Conditions: Thrombosis; Bleeding Disorder; Extra Corporeal Life Support
• Interventions: Diagnostic Test: Standard coagulation profile; Diagnostic Test: Specific coagulation tests; Other: Bleeding Scores

• Registration Number: NCT04912336
• Lead Sponsor: University Hospital, Ghent

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

Study Timeline

• Study First Submitted: 2021-05-06
• Study Start: 2021-05-28
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-03
• Primary Completion: 2023-01-16
• Study Completion: 2024-04-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VA-ECMO	Bleeding Scores	Patients supported because of circulatory failure by Veno-Arterial Extra Corporeal Membrane Oxygenator.
VV-ECMO	Specific coagulation tests	Patients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator.
VA-ECMO	Specific coagulation tests	Patients supported because of circulatory failure by Veno-Arterial Extra Corporeal Membrane Oxygenator.
VV-ECMO	Standard coagulation profile	Patients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator.
VA-ECMO	Standard coagulation profile	Patients supported because of circulatory failure by Veno-Arterial Extra Corporeal Membrane Oxygenator.
VV-ECMO	Bleeding Scores	Patients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator.

Primary Outcome Measures

Name	Time	Method
Thrombocytopenia	48 hours	Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients

Secondary Outcome Measures

Name	Time	Method
Need for transfusion	48 hours	Need for transfusion of packed red blood cells
Change in visco-elastic testing	At 2 hours, 24 hours, 48 hours	ROTEM changes
Survival	1 year	survival in the ICU, in the hospital, at day 28, day 90, 6months and 1 year
Bleeding problems, Type 2 Bleeding according to BARC criteria or moderate bleeding according to GUSTO criteria	48 hours	incidence of clinical overt bleeding
Clotting problems	48 hours	Incidence of deep venous trombosis or emboli or ECMO circuit problems due to clotting

Trial Locations

Locations (6)

Centre Hospitalier Universitaire Liege; 🇧🇪 Liège, Belgium

University Hospital Brussels; 🇧🇪 Jette, Belgium

CHU UCL Namur- Godinne; 🇧🇪 Yvoir, Namen, Belgium

Ghent University Hospital; 🇧🇪 Ghent, Belgium

University Hospital Münster; 🇩🇪 Münster, Germany

CHU Charleroi; 🇧🇪 Lodelinsart, Henegouwen, Belgium