Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low anticoagulation dose of argatroban and enoxaparin during ECMO, Standard anticoagulation dose of argatroban and enoxaparin during ECMO.
- Who it may be relevant to
- Registry conditions: Pneumonia, Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Low-dose Versus Standard-dose Anticoagulation With Argatroban and Enoxaparin During Extracorporeal Membrane Oxygenation Controlled by Anti-IIa and An-ti-Xa, Respectively
Overview
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.
Detailed description
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.
Interventions
- Drug 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 - Drug 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 measures
- Safety of bleeding complications [Time frame: During ECMO, up to 4 weeks]
- Safety of thrombotic complications [Time frame: During ECMO, up to 4 weeks]
Secondary outcome measures (4)
- Mortality [Time frame: 6 months]
- Cerebral Performance Category (CPC) score [Time frame: 30 days]
- Quality of Life questionnaires score - EQ-5D-5L [Time frame: 6 months]
- Quality of Life questionnaires score - SF36 [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Czechia · 2 centers
- University Hospital Ostrava — Ostrava
- University Hospital Motol — Prague
Identifiers
NCT: NCT07499037 · KARIM-ECMO