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ClinicalTrials.gov ID

NCT07499037

Lead Sponsor

University Hospital OstravaOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

200Estimated

Last Update Posted

Apr 2, 2026Actual

Start Date

Jan 2027Estimated

Primary Completion Date

Sep 2029Estimated

Completion Date

Dec 2029Estimated

Official Title

Low-dose Versus Standard-dose Anticoagulation With Argatroban and Enoxaparin During Extracorporeal Membrane Oxygenation Controlled by Anti-IIa and An-ti-Xa, Respectively

Brief Summary

The standard and most common therapy is anticoagulation with heparin according to activated partial thromboplastin time (aPTT) during extracorporeal membrane oxygenation (ECMO) support. The study will focus on evaluating the efficacy and safety of new anticoagulants on ECMO, namely argatroban and enoxaparin in lower doses controlled according to targeted antiIIa and antiXa markers.

Detailed Description

This is a phase II academic clinical trial designed to evaluate the effect of argatroban and enoxaparin used to enable ECMO support in critically ill patients. The population will consist of patients hospitalised at University Hospital Ostrava and University Hospital Motol Prague. After signing the Informed Con-sent to participate in the study, treatment will be based on the patient's clinical condition and the decision of the attending physician. The study participants will be patients diagnosed with heart failure (including cardiac arrest) or pulmonary failure, adult men and women, using argatroban or enoxaparin.

• Pneumonia
• Heart Failure

• Low anticoagulation dose of argatroban and enoxaparin during ECMO
• Standard anticoagulation dose of argatroban and enoxaparin during ECMO

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• ECMO support with anticoagulation using argatroban/enoxaparin
• Age ≥ 18 years
• Obtaining informed consent in accordance with the procedure specified in the protocol

Exclusion Criteria:

• Enrolment in the lung transplant program at Motol University Hospital
• Known hypersensitivity to the components of the evaluated products
• Allergic reaction to the active ingredients of the evaluated products
• Pregnancy and breastfeeding

Primary Purpose

Treatment

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital OstravaOTHER

Collaborators

University Hospital, MotolOTHER

jaromir.vajter@fnmotol.cz+420603512475