Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

Completed

• Conditions: COVID-19; ARDS
• Interventions: Drug: Argatroban Injection; Drug: Heparin

• Registration Number: NCT06038682
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2023-07-31
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-08
• Study First Posted: 2023-09-15
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Argatroban anticoagulation	Argatroban Injection	Study subjects in this group will receive Argatroban anticoagulation.
Heparin anticoagulation	Heparin	Study subjects in this group will receive Heparin anticoagulation.

Primary Outcome Measures

Name	Time	Method
Comparison of aPTT values with anti-IIa and Argatroban dose in patients on VV ECMO	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
Comparison of apt and anti-Xa values and heparin dose in patients on VV ECMO	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 Outcome Measures

Name	Time	Method
Frequency and severity of bleeding complications	up to 2 weeks	Comparison of frequency and severity of bleeding complications in patients on anticoagulation with Argatroban and heparin
Frequency and severity of thrombotic complications	up to 2 weeks	Comparison of frequency and severity of thrombotic complications in patients anticoagulated with Argatroban and heparin
Consumption of blood products (in ml)	up to 2 weeks	The consumption of blood products (volume in ml) in patients on Argatroban and heparin

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia