Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMO

March 27, 2026 updated by: University Hospital Ostrava

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia, 150 00
        • University Hospital Motol
        • Contact:
        • Principal Investigator:
          • Jaromír Vajter, MD,Ph.D.
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • University Hospital Ostrava
        • Contact:
        • Principal Investigator:
          • Filip Burša, MD,Ph.D.,EDEC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low anticoagulation dose of argatroban and enoxaparin during ECMO
Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO.
Drug: Low anticoagulation dose of argatroban and enoxaparin during ECMO
Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO
Experimental: Standard anticoagulation dose of argatroban and enoxaparin during ECMO
Study subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO.
Drug: Standard anticoagulation dose of argatroban and enoxaparin during ECMO
Study subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of bleeding complications
Time Frame: During ECMO, up to 4 weeks
Bleeding Academic Research Consortium (BARC) score will be used to assess bleeding complication.
During ECMO, up to 4 weeks
Safety of thrombotic complications
Time Frame: During ECMO, up to 4 weeks
ECMO pressures (e.g. oxygenator changes) will be used to assess thrombotic complications
During ECMO, up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 6 months
Hospital mortality and 6-month mortality will be assessed
6 months
Cerebral Performance Category (CPC) score
Time Frame: 30 days
Cerebral Performance Category (CPC) score will be assessed on the 30th day after ECMO initiation
30 days
Quality of Life questionnaires score - EQ-5D-5L
Time Frame: 6 months
Quality of Life will be assessed using the EQ-5D-5L questionnaire 6 months after ECMO initiation. The EQ-5D-5L questionnaire is a quick, 5-dimension preference-based tool (mobility, self-care, activities, pain, anxiety) with a visual analog scale (VAS).
6 months
Quality of Life questionnaires score - SF36
Time Frame: 6 months
Quality of Life will be assessed using the SF36 questionnaire 6 months after ECMO initiation. SF-36 is a comprehensive 36-item survey assessing eight health domains.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

University Hospital, Motol

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KARIM-ECMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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