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Low-dose versus standard-dose anticoagulation with argatroban or enoxaparin during extracorporeal membrane oxygenation controlled by anti-IIa or anti-Xa assay

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524553-13-00
Enrollment
200
Registered
2026-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung and/or heart failure

Brief summary

To comprehensively compare the efficacy and safety of anticoagulation therapy in patients on ECMO support with argatroban, enoxaparin and in the combined population of patients with argatroban or enoxaparin

Detailed description

To determine the relationship between argatroban concentration and the incidence of bleeding and thrombotic complications and the consumption of blood derivatives and transfusion products, To determine the relationship between the dose or concentration of anticoagulant and laboratory parameters for monitoring anticoagulation, To determine the relationship between laboratory parameters and bleeding and thrombotic complications

Interventions

DRUGArgatra Multidose 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGCLEXANE 10 000 IU (100 mg)/1 ml injekční roztok v předplněné injekční stříkačce

Sponsors

Fakultni Nemocnice Ostrava
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To comprehensively compare the efficacy and safety of anticoagulation therapy in patients on ECMO support with argatroban, enoxaparin and in the combined population of patients with argatroban or enoxaparin

Secondary

MeasureTime frame
To determine the relationship between argatroban concentration and the incidence of bleeding and thrombotic complications and the consumption of blood derivatives and transfusion products, To determine the relationship between the dose or concentration of anticoagulant and laboratory parameters for monitoring anticoagulation, To determine the relationship between laboratory parameters and bleeding and thrombotic complications

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 20, 2026