Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07499037

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Pneumonia Cardiovascular Diseases Heart Diseases Heart Failure Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Low anticoagulation dose of argatroban and enoxaparin during ECMO

Drug

Study subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO

Standard anticoagulation dose of argatroban and enoxaparin during ECMO

Drug

Study subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Mortality

    Time frame: 6 months

    Hospital mortality and 6-month mortality will be assessed

  2. Cerebral Performance Category (CPC) score

    Time frame: 30 days

    Cerebral Performance Category (CPC) score will be assessed on the 30th day after ECMO initiation

  3. 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).

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

+42059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • University Hospital, Motol

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2029
Study completion
2029
First posted
Mar 27, 2026
Registry last updated
Apr 2, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.