Extracorporeal Life Support and Modification of Hemostasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-28

Study Completion Date

2024-04-30

Brief Summary

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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).

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Detailed Description

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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

Conditions

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Bleeding Disorder Extra Corporeal Life Support Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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VV-ECMO

Patients supported because of respiratory failure by Veno-Venous Extra Corporeal Membrane Oxygenator.

Standard coagulation profile

Intervention Type DIAGNOSTIC_TEST

prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount

Specific coagulation tests

Intervention Type DIAGNOSTIC_TEST

AT III, anti Xa, ACT, ROTEM

Bleeding Scores

Intervention Type OTHER

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.

Standard coagulation profile

Intervention Type DIAGNOSTIC_TEST

prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount

Specific coagulation tests

Intervention Type DIAGNOSTIC_TEST

AT III, anti Xa, ACT, ROTEM

Bleeding Scores

Intervention Type OTHER

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

Interventions

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Standard coagulation profile

prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount

Intervention Type DIAGNOSTIC_TEST

Specific coagulation tests

AT III, anti Xa, ACT, ROTEM

Intervention Type DIAGNOSTIC_TEST

Bleeding Scores

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

Intervention Type OTHER

Eligibility Criteria

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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