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

Sponsor
University Hospital Ostrava
Study ID
NCT07499037
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Mar 27, 2026
Start date
Jan 31, 2027
Status verified
Mar 2026
Primary completion
Sep 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Safety of bleeding complications [ Time Frame: During ECMO, up to 4 weeks ]

Central Contacts

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