Extracorporeal Life Support and Modification of Hemostasis (ELMOH)

Extra Corporeal 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).

Study Overview

• Status: Active, not recruiting
• Conditions: Thrombosis; Bleeding Disorder; Extra Corporeal Life Support
• Intervention / Treatment: Diagnostic test: Standard coagulation profile; Diagnostic test: Specific coagulation tests; Other: Bleeding Scores

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 Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

• Study Contact: Name: Harlinde Peperstraete, MD; Phone Number: +32 93325185; Email: harlinde.peperstraete@uzgent.be
• Study Contact Backup: Name: Eric Hoste, MD PhD; Phone Number: +32 9 3324197; Email: eric.hoste@ugent.be

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Jette, Belgium, 1090
    • University Hospital Brussels
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire Liege
  • Henegouwen
    • Lodelinsart, Henegouwen, Belgium, 6042
      • Chu Charleroi
  • Namen
    • Yvoir, Namen, Belgium, 5530
      • CHU UCL Namur- Godinne
• Germany
  • Münster, Germany, 48149
    • University Hospital Münster

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VV-ECMO; Patients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator.	Diagnostic test: Standard coagulation profile; prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount; Diagnostic test: 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)
VA-ECMO; Patients supported because of circulatory failure by Veno-Arterial Extra Corporeal Membrane Oxygenator.	Diagnostic test: Standard coagulation profile; prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount; Diagnostic test: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombocytopenia	Moderate thrombocytopenia lower than 150 x 103/µL in 25% of recruited patients	48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Harlinde Peperstraete, MD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): January 16, 2023
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Embolism and Thrombosis; Hemostatic Disorders; Blood Coagulation Disorders; Thrombosis
• Other Study ID Numbers: BC-07099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: All data will be put in Redcap. At inclusion, at inclusion +2h, at inclusion +24 and at inclusion +48h: a clotting panel and clinical observation about bleedina and clotting will be performed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No