Monitoring Anticoagulation in Patients on ECMO for Severe Lung Failure

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ClinicalTrials.gov Identifier: NCT06038682

Recruitment Status : Completed

First Posted : September 15, 2023

Last Update Posted : March 1, 2024

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Sponsor:

Information provided by (Responsible Party):

University Hospital Ostrava

Study Description

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.

Condition or disease	Intervention/treatment
ARDS COVID-19	Drug: Argatroban Injection Drug: Heparin

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 Design

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Study Type :	Observational
Actual Enrollment :	100 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official 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.
Actual Study Start Date :	April 1, 2020
Actual Primary Completion Date :	July 31, 2023
Actual Study Completion Date :	December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin Heparin sodium Argatroban

Genetic and Rare Diseases Information Center resources: Respiratory Distress Syndrome, Infant Acute Respiratory Distress Syndrome Acute Graft Versus Host Disease

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Argatroban anticoagulation Study subjects in this group will receive Argatroban anticoagulation.	Drug: Argatroban Injection Argatroban will be administered to the study subjects in this group in order to achieve anticoagulation.
Heparin anticoagulation Study subjects in this group will receive Heparin anticoagulation.	Drug: Heparin Heparin will be administered to the study subjects in this group in order to achieve anticoagulation.

Outcome Measures

Primary Outcome Measures :

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
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 Outcome Measures :

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
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
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

Biospecimen Retention: Samples Without DNA

Blood samples will be obtained from patients in course of the routine care.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Non-Probability Sample

Study Population

Patients on VV (veno-venous) ECMO on anticoagulation with Argatroban or heparin.

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06038682

Locations

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Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia, 70852

Sponsors and Collaborators

University Hospital Ostrava

Investigators

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Principal Investigator:	Filip Burša, MD, Ph.D.	University Hospital Ostrava

More Information

Publications:

Al-Samkari H, Gupta S, Leaf RK, Wang W, Rosovsky RP, Brenner SK, Hayek SS, Berlin H, Kapoor R, Shaefi S, Melamed ML, Sutherland A, Radbel J, Green A, Garibaldi BT, Srivastava A, Leonberg-Yoo A, Shehata AM, Flythe JE, Rashidi A, Goyal N, Chan L, Mathews KS, Hedayati SS, Dy R, Toth-Manikowski SM, Zhang J, Mallappallil M, Redfern RE, Bansal AD, Short SAP, Vangel MG, Admon AJ, Semler MW, Bauer KA, Hernan MA, Leaf DE; STOP-COVID Investigators. Thrombosis, Bleeding, and the Observational Effect of Early Therapeutic Anticoagulation on Survival in Critically Ill Patients With COVID-19. Ann Intern Med. 2021 May;174(5):622-632. doi: 10.7326/M20-6739. Epub 2021 Jan 26. Erratum In: Ann Intern Med. 2021 Jun;174(6):888.

Kowalewski M, Fina D, Slomka A, Raffa GM, Martucci G, Lo Coco V, De Piero ME, Ranucci M, Suwalski P, Lorusso R. COVID-19 and ECMO: the interplay between coagulation and inflammation-a narrative review. Crit Care. 2020 May 8;24(1):205. doi: 10.1186/s13054-020-02925-3.

Godier A, Clausse D, Meslin S, Bazine M, Lang E, Huche F, Cholley B, Hamada SR. Major bleeding complications in critically ill patients with COVID-19 pneumonia. J Thromb Thrombolysis. 2021 Jul;52(1):18-21. doi: 10.1007/s11239-021-02403-9. Epub 2021 Mar 1.

Gils C, Vinholt PJ, Nybo M. Falsely prolonged activated partial thromboplastin time - a pre- and post-analytical issue. Biochem Med (Zagreb). 2019 Feb 15;29(1):011001. doi: 10.11613/BM.2019.011001. Epub 2018 Dec 15.

Seelhammer TG, Plack D, Lal A, Nabzdyk CGS. COVID-19 and ECMO: An Unhappy Marriage of Endothelial Dysfunction and Hemostatic Derangements. J Cardiothorac Vasc Anesth. 2020 Dec;34(12):3193-3196. doi: 10.1053/j.jvca.2020.09.132. Epub 2020 Oct 2. No abstract available.

Alberio L, Angelillo-Scherrer A, Asmis L, Casini A, Fontana P, Graf L, Hegemann I, Kremer Hovinga JA, Korte W, Lecompte T, Martinez M, Nagler M, Studt JD, Tsakiris DA, Wuillemin W. Recommendations on the use of anticoagulants for the treatment of patients with heparin-induced thrombocytopenia in Switzerland. Swiss Med Wkly. 2020 Apr 24;150:w20210. doi: 10.4414/smw.2020.20210. eCollection 2020 Apr 20.

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Responsible Party:	University Hospital Ostrava
ClinicalTrials.gov Identifier:	NCT06038682
Other Study ID Numbers:	FNO-KARIM-Argatroban
First Posted:	September 15, 2023 Key Record Dates
Last Update Posted:	March 1, 2024
Last Verified:	February 2024

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by University Hospital Ostrava:


ECMO ARDS (acute respiratory distress syndrome) anticoagulation	thrombotic complications LMWH (low-molecular-weight heparin) Argatroban

Additional relevant MeSH terms:

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Heparin Argatroban Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action	Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Platelet Aggregation Inhibitors

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