PneumoniaPhase 2NCT07499037
Safety and Efficacy of Low-dose Anticoagulation With Argatroban and Enoxaparin on ECMO
A Phase 2 study testing Low anticoagulation dose of argatroban and enoxaparin during ECMO and Standard anticoagulation dose of argatroban and enoxaparin during ECMO in people with Pneumonia and Heart Failure, run by University Hospital Ostrava at 2 sites in Czechia.
Trial summary
The standard and most common therapy is anticoagulation with heparin according to activated partial thromboplastin time (aPTT) during extracorporeal membrane oxygenation (ECMO) support. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Heart Failure
- What is being tested?
- Low anticoagulation dose of argatroban and enoxaparin during ECMO and Standard anticoagulation dose of argatroban and enoxaparin during ECMO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCzechia
- Study dates
- Jan 2027to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECMO support with anticoagulation using argatroban/enoxaparin
- Age ≥ 18 years
- Obtaining informed consent in accordance with the procedure specified in the protocol
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia2 sites
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
Jiří Hynčica, +42059737 ext. 2587, jiri.hyncica@fno.cz
Filip Burša, MD,Ph.D.,EDEC
University Hospital Motol
Prague, 150 00
Jaromír Vajter, MD,Ph.D., +420603512475, jaromir.vajter@fnmotol.cz
Jaromír Vajter, MD,Ph.D.
About this study
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
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.
Read the 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.
- Conditions
- Pneumonia, Heart Failure
- Being tested
- Low anticoagulation dose of argatroban and enoxaparin during ECMO, Standard anticoagulation dose of argatroban and enoxaparin during ECMO
- Keywords
- ECMO, Pneumonia, Heart failure, Anticoagulation
- Medical subject headings
- Pneumonia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard anticoagulation dose of argatroban and enoxaparin during ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of bleeding complications
Bleeding Academic Research Consortium (BARC) score will be used to assess bleeding complication.
Measured: During ECMO, up to 4 weeks
Safety of thrombotic complications
ECMO pressures (e.g. oxygenator changes) will be used to assess thrombotic complications
Measured: During ECMO, up to 4 weeks
Secondary outcomes (4)
Mortality
Hospital mortality and 6-month mortality will be assessed
Measured: 6 months
Cerebral Performance Category (CPC) score
Cerebral Performance Category (CPC) score will be assessed on the 30th day after ECMO initiation
Measured: 30 days
Quality of Life questionnaires score - EQ-5D-5L
Quality of Life will be assessed using the EQ-5D-5L questionnaire 6 months after ECMO initiation. The EQ-5D-5L questionnaire is a quick, 5-dimension preference-based tool (mobility, self-care, activities, pain, anxiety) with a visual analog scale (VAS).
Measured: 6 months
Quality of Life questionnaires score - SF36
Quality of Life will be assessed using the SF36 questionnaire 6 months after ECMO initiation. SF-36 is a comprehensive 36-item survey assessing eight health domains.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study startJan 2027 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study subjects will be enrolled in two parallel groups.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Motol
- Responsible party
- Sponsor
- Investigators
- Filip Burša, MD,Ph.D.,EDEC, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499037
- Sponsor's protocol ID
- KARIM-ECMO
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07499037
- Acronym / sponsor ID
- KARIM-ECMO
- Conditions
- Pneumonia, Heart Failure
- Keywords
- ECMO, Pneumonia, Heart failure, Anticoagulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University Hospital, Motol
- Study start
- Jan 2027 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study subjects will be enrolled in two parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Low anticoagulation dose of argatroban and enoxaparin during ECMO | Experimental | Drug: Low anticoagulation dose of argatroban and enoxaparin during ECMOStudy subjects in this group will receive low anticoagulation dose of argatroban and enoxaparin during ECMO. |
| Standard anticoagulation dose of argatroban and enoxaparin during ECMO | Experimental | Drug: Standard anticoagulation dose of argatroban and enoxaparin during ECMOStudy subjects in this group will receive standard anticoagulation dose of argatroban and enoxaparin during ECMO. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ECMO support with anticoagulation using argatroban/enoxaparin
- Age ≥ 18 years
- Obtaining informed consent in accordance with the procedure specified in the protocol
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low anticoagulation dose of argatroban and enoxaparin during ECMOStudy 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 ECMOStudy 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 |
Primary outcome
Safety of bleeding complications
Time frame: During ECMO, up to 4 weeks
Bleeding Academic Research Consortium (BARC) score will be used to assess bleeding complication.
Safety of thrombotic complications
Time frame: During ECMO, up to 4 weeks
ECMO pressures (e.g. oxygenator changes) will be used to assess thrombotic complications
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Filip Burša, MD,Ph.D.,EDEC principal investigator
University Hospital Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Low anticoagulation dose of argatroban and enoxaparin during ECMO and Standard anticoagulation dose of argatroban and enoxaparin during ECMO in people with Pneumonia and Heart Failure, run by University Hospital Ostrava at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiří Hynčica (+42059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of bleeding complications (time frame: During ECMO, up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.