Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
200
Countries
1
Sites
2
lung and/or heart failure
Description of the efficacy and safety of low dose (LD) and standard dose (SD) anticoagulation with argatroban and enoxaparin in patients on ECMO support.
Key facts
- Sponsor
- Fakultni Nemocnice Ostrava
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2026-03-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Fakultní nemocnice Ostrava
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response
Description of the efficacy and safety of low dose (LD) and standard dose (SD) anticoagulation with argatroban and enoxaparin in patients on ECMO support.
Secondary objectives 6
- Hospital mortality
- Six-month mortality
- Assessment of the effect of dosage on the consumption of blood derivatives and transfusion products.
- Comparison of the frequency of ECMO circuit replacement between the LD and SD groups.
- Cerebral Performance Category (CPC) score assessment at hospital discharge, on day 30 after initiation of the ECMO therapy, and 6 months after initiation of the ECMO therapy.
- Quality of life assessment using standard SF-36 and EQ-5D-5L questionnaires after 6 months from initiation of the ECMO therapy.
Conditions and MedDRA coding
lung and/or heart failure
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 28.0 | LLT | 10084748 | ECMO therapy | 100000004848 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment ECMO therapy
|
Randomised Controlled | None | Argatroban low dose (LD): Study subjects in this arm will receive argatroban in low dose. Argatroban standard dose (SD): Study subjects in this arm will receive argatroban in standard dose. Enoxaparin low dose (LD): Study subjects in this arm will receive enoxaparin in low dose. Enoxaparin standard dose (SD): Study subjects in this arm will receive enoxaparin in standard dose. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- ECMO support with argatroban / enoxaparin anticoagulation
- Age ≥ 18 years
- Obtaining informed consent according to the procedure specified in the protocol
Exclusion criteria 4
- Inclusion in the lung transplant program at Motol Hospital
- Known hypersensitivity to components of the investigational medicinal products
- Allergic reaction to the active substances of the investigational medicinal products
- Pregnancy and breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 3
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
CLEXANE 10 000 IU (100 mg)/1 ml injekční roztok v předplněné injekční stříkačce
PRD434769 · Product
- Active substance
- Enoxaparin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 480 IU/Kg iu/kilogram
- Max total dose
- 13440 IU/Kg iu/kilogram
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AB05 — ENOXAPARIN
- Marketing authorisation
- 16/250/93-E/C
- MA holder
- SANOFI S.R.O.
- MA country
- Czech Republic
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Argatra Multidose 100 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD11860707 · Product
- Active substance
- Argatroban Monohydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 0.05 mg/Kg milligram(s)/kilogram
- Max total dose
- 1.5 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- B01AE03 — -
- Marketing authorisation
- 1-29763
- MA holder
- ETHYPHARM
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fakultni Nemocnice Ostrava
- Sponsor organisation
- Fakultni Nemocnice Ostrava
- Address
- 17. Listopadu 1790/5, Poruba Poruba
- City
- Ostrava
- Postcode
- 708 00
- Country
- Czechia
Scientific contact point
- Organisation
- Fakultni Nemocnice Ostrava
- Contact name
- Filip Burša, MD, Ph.D., EDEC
Public contact point
- Organisation
- Fakultni Nemocnice Ostrava
- Contact name
- Jiří Hynčica
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruitment pending | 200 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protokol_KH_2025_524553-13-00 | 1.0 |
| Protocol (for publication) | D1_Protokol_KH_v1_1_2025_524553-13-00_TC | 1.1 |
| Recruitment arrangements (for publication) | K1_Nabor_SH_2025_524553-13-00 | N/A |
| Subject information and informed consent form (for publication) | L1_ICF_GDPR_2025-524553-13-00_placeholder | N/A |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GDPR_2025-524553-13-00 | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main+GDPR_2025-524553-13-00_v2 | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main+GDPR_2025-524553-13-00_v2_TC | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1-IB_SmPC Argatra_cs-a-ds | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E1-IB_SmPC_Clexane | N/A |
| Synopsis of the protocol (for publication) | D1_Souhrn_protokolu_2025_524553-13-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Souhrn_protokolu_v1_1_2025_524553-13-00 | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-11 | Czechia | Acceptable 2026-03-19
|
2026-03-19 |