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

ConditionsPneumoniaHeart Failure
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Ostrava

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECMO support with anticoagulation using argatroban/enoxaparin

Age ≥ 18 years

Obtaining informed consent in accordance with the procedure specified in the protocol

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Low anticoagulation dose of argatroban and enoxaparin during ECMOExperimental treatment 1 intervention
Group B: Standard anticoagulation dose of argatroban and enoxaparin during ECMOExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of bleeding complications

Bleeding Academic Research Consortium (BARC) score will be used to assess bleeding complication.

Time frame
During ECMO, up to 4 weeks
2

Safety of thrombotic complications

ECMO pressures (e.g. oxygenator changes) will be used to assess thrombotic complications

Time frame
During ECMO, up to 4 weeks

Secondary outcomes

1

Mortality

Hospital mortality and 6-month mortality will be assessed

Time frame
6 months
2

Cerebral Performance Category (CPC) score

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

Time frame
30 days
3

Quality of Life questionnaires score - EQ-5D-5L

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).

Time frame
6 months
4

Quality of Life questionnaires score - SF36

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.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital Ostrava

Lead sponsor

University Hospital, Motol

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: