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Completed

NCT Number: NCT06038682

Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

A monocentric observational study evaluates the accuracy of anticoagulation monitoring in critically ill patients on ECLS (extracorporeal life support) using new markers of the effect of direct thrombin inhibitors and also the accuracy of anticoagulation monitoring in patients on unfractionated heparin using anti-Xa. A more accurate setting of anticoagulation may lead to a reduction in the number of serious bleeding and thrombotic complications in these patients.

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Key information

Conditions

ARDS Acute Lung Injury COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Lung Injury Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

About this study

Anticoagulation using a direct thrombin inhibitor, argatroban, is one of the modern options for anticoagulation in patients on VV (veno-venous) ECMO (extracorporeal membrane oxygenation) support, and in 2021 the ECMO center of the University Hospital Ostrava changed the standard anticoagulation using UHF (unfractionated heparin) to anticoagulation using Argatroban as a new standard of routine care. Argatroban shows more stable levels and has a short half-life, and a number of foreign ECMO centers have been using Argatroban for a long time also as basic anticoagulation in all ECMO patients.

To monitor the effect of direct thrombin inhibitors, it is possible to use monitoring of anti-FIIa activity, which directly assesses the effect of the anticoagulant on thrombin activity. Anticoagulation with Argatroban may reduce the risk of serious bleeding complications. Target values of aPTT (Activated Partial Thromboplastin Time) and anti-FIIa can be determined according to ELSO (Extracorporeal Life Support Organization) guidelines.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with COVID-19
  • ARDS according to the Berlin definition
  • Veno-venous (VV) ECMO
  • Full coagulation with Argatroban or heparin to an anti-FIIa value of 0.4-1.5 or aPTT 50-60

Exclusion criteria

  • age under 18 years

Treatment and study plan

Argatroban Injection

Drug

Argatroban will be administered to the study subjects in this group in order to achieve anticoagulation.

Heparin

Drug

Heparin will be administered to the study subjects in this group in order to achieve anticoagulation.

Primary outcomes

  1. Comparison of aPTT values with anti-IIa and Argatroban dose in patients on VV ECMO

    Time frame: up to 2 weeks

    Comparison of correlation of aPTT and anti-IIa with dynamics of D dimer, FDP (fibrin degradation product) and acute phase reactants of ferritin, CRP (C-reactive protein) Correlation of bleeding complications with aPTT, anti-IIa, platelets

  2. Comparison of apt and anti-Xa values and heparin dose in patients on VV ECMO

    Time frame: up to 2 weeks

    Comparison of correlation of aPTT and anti-Xa with dynamics of D dimer, FDP and acute phase reactants of ferritin, CRP

Secondary outcomes

  1. Frequency and severity of bleeding complications

    Time frame: up to 2 weeks

    Comparison of frequency and severity of bleeding complications in patients on anticoagulation with Argatroban and heparin

  2. Frequency and severity of thrombotic complications

    Time frame: up to 2 weeks

    Comparison of frequency and severity of thrombotic complications in patients anticoagulated with Argatroban and heparin

  3. Consumption of blood products (in ml)

    Time frame: up to 2 weeks

    The consumption of blood products (volume in ml) in patients on Argatroban and heparin

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

Monitoring Anticoagulation With Argatroban in Patients on Extracorporeal Membrane Oxygenation for Severe Lung Failure Using Anti-FIIa. Monitoring Anticoagulation With Unfractionated Heparin in Patients on Extracorporeal Membrane Oxygenation for Severe Lung Failure Using Anti-FXa.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2023
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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