NCT07499037

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
36mo left

Started Jan 2027

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

March 18, 2026

Last Update Submit

March 27, 2026

Conditions

PneumoniaHeart Failure

Keywords

ECMOPneumoniaHeart failureAnticoagulation

Outcome Measures

Primary Outcomes (2)

  • Safety of bleeding complications

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

    During ECMO, up to 4 weeks

  • Safety of thrombotic complications

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

    During ECMO, up to 4 weeks

Secondary Outcomes (4)

  • Mortality

    6 months

  • Cerebral Performance Category (CPC) score

    30 days

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

    6 months

  • Quality of Life questionnaires score - SF36

    6 months

Study Arms (2)

Low anticoagulation dose of argatroban and enoxaparin during ECMO

EXPERIMENTAL

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

Standard anticoagulation dose of argatroban and enoxaparin during ECMO

EXPERIMENTAL

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

Interventions

Low anticoagulation dose of argatroban and enoxaparin during ECMODRUG

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

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

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

Standard anticoagulation dose of argatroban and enoxaparin during ECMO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

University Hospital Motol

Prague, 150 00, Czechia

Location

MeSH Terms

Conditions

PneumoniaHeart Failure

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Filip Burša, MD,Ph.D.,EDEC

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiří Hynčica

CONTACT

+42059737jiri.hyncica@fno.cz

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking will be used in the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study subjects will be enrolled in two parallel groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 27, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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

Locations

CZ(2)