Refractory Respiratory FailureNCT06010446
Intravenous Continuous LMWH Seems to be Safe Alternative to UFH in VV ECMO Patients
An observational study of Refractory Respiratory Failure, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended anticoagulation in patients with ECMO support. However, it is accompanied with incidence of bleeding or thrombotic compliaction at about 40-60% and high mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Respiratory Failure
- How many people
- 43 participants
- Where
- 1 siteCzechia
- Study dates
- 15 May 2019to 15 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: patients with respiratory failure put VV ECMO
Who may be able to join
- VV ECMO - use of 2 separate cannulas (jugular and femoral)
- anticoagulation with only intravenous continuous LMWH (Enoxaparin)
- only a period of the first ECMO set running
Who cannot join
- pregnancy
- Avalon cannula (one double lumen cannula)
- patients after thoraco-abdominal surgery
- patients after lung transplantation in early postoperative period
- patients after trauma without any type of heparin ,,heparin free" ECMO
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care
Prague, 150 06
About this study
Official title: Intravenous Continuous LMWH (Enoxaparin) Seems to be Safe Alternative to UFH in Patients With VV ECMO
Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended anticoagulation in patients with ECMO support. However, it is accompanied with incidence of bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis and thrombosis development in patients.
We decided to performed retrospective observation study and analysis of data, from may 2019 until august 2023, in all patients who were put on VV ECMO and to analysis incidence of bleeding, thrombotic and neurologic complications.
Read the detailed description
Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended anticoagulation in patients with ECMO support. However, it is accompanied with incidence of bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis and thrombosis development in patients. This phenomenon of primary haemosthasis pathology may protect ECMO from thrombotic complication as primary haemosthasis plays major role in haemosthasis taking places in high shear stress condiditon such as ECMO. Because LMWH is connected with lower incidence of bleeding complication and HIT (heparin induced thrombocytopenia) in general, in case that patients on VV ECMO developed primary haemosthasis pathology detected by PFA 200, we started to use LMWH instead of UFH in VV ECMO patients.
We decided to performed retrospective observation study and analysis of data, from may 2019 until august 2023, in all patients who were put on VV ECMO and to analysis incidence of bleeding, thrombotic and neurologic complications. We want to compare this incidence of compliactions with data known from patients with other studies using UFH.
- Conditions
- Refractory Respiratory Failure
- Being tested
- No intervention, just retrospective analysis of data.
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, just retrospective analysis of data.Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major bleeding complications
Defined by ECMO registry
Measured: Daty from may 2019 till august 2023
Incidence of major thrombotic complications
Defined by ECMO registry
Measured: Daty from may 2019 till august 2023
Incidence of major neurologic complications
Defined by ECMO registry
Measured: Daty from may 2019 till august 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start15 May 2019
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Refractory Respiratory FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Durila Miroslav MUDr. Ph.D., University Hospital, Motol
- Investigators
- Miroslav Durila, prof., Principal investigator, Department of anesthesiology and intensive care medicine, Motol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010446
- Sponsor's protocol ID
- 15082023
- Status last verified
- Feb 2025
- First submitted
- 15 Aug 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Durila M, Vajter J, Garaj M, Berousek J, Lischke R, Hlavacek M, Vymazal T. Intravenous enoxaparin guided by anti-Xa in venovenous extracorporeal membrane oxygenation: A retrospective, single-center study. Artif Organs. 2025 Mar;49(3):486-496. doi: 10.1111/aor.14879. Epub 2024 Oct 3.
PubMed 39360891
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Continuous LMWH (Enoxaparin) Seems to be Safe Alternative to UFH in Patients With VV ECMO
- ClinicalTrials.gov ID
- NCT06010446
- Acronym / sponsor ID
- 15082023
- Conditions
- Refractory Respiratory Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 24 Aug 2023 (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.
Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended anticoagulation in patients with ECMO support. However, it is accompanied with incidence of bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis and thrombosis development in patients.
We decided to performed retrospective observation study and analysis of data, from may 2019 until august 2023, in all patients who were put on VV ECMO and to analysis incidence of bleeding, thrombotic and neurologic complications.
Detailed description
Unfractionated heparin (UFH) is worldwide anticoagulation used and recommended anticoagulation in patients with ECMO support. However, it is accompanied with incidence of bleeding or thrombotic compliaction at about 40-60% and high mortality. Because ECMO produce primary haemosthasis pathology, there is a theory that prophylaxis of thrombosis with low molecular weight heparin (LMWH) e.g. Enoxaparin might be sufficient to prevent ECMO throbosis and thrombosis development in patients. This phenomenon of primary haemosthasis pathology may protect ECMO from thrombotic complication as primary haemosthasis plays major role in haemosthasis taking places in high shear stress condiditon such as ECMO. Because LMWH is connected with lower incidence of bleeding complication and HIT (heparin induced thrombocytopenia) in general, in case that patients on VV ECMO developed primary haemosthasis pathology detected by PFA 200, we started to use LMWH instead of UFH in VV ECMO patients.
We decided to performed retrospective observation study and analysis of data, from may 2019 until august 2023, in all patients who were put on VV ECMO and to analysis incidence of bleeding, thrombotic and neurologic complications. We want to compare this incidence of compliactions with data known from patients with other studies using UFH.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with respiratory failure put VV ECMO
Key inclusion criteria (3 listed)
- VV ECMO - use of 2 separate cannulas (jugular and femoral)
- anticoagulation with only intravenous continuous LMWH (Enoxaparin)
- only a period of the first ECMO set running
Key exclusion criteria (5 listed)
- pregnancy
- Avalon cannula (one double lumen cannula)
- patients after thoraco-abdominal surgery
- patients after lung transplantation in early postoperative period
- patients after trauma without any type of heparin ,,heparin free" ECMO
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 |
|---|---|---|
| No intervention, just retrospective analysis of data. | Other | – |
Primary outcome
Incidence of major bleeding complications
Time frame: Daty from may 2019 till august 2023
Defined by ECMO registry
Incidence of major thrombotic complications
Time frame: Daty from may 2019 till august 2023
Defined by ECMO registry
Incidence of major neurologic complications
Time frame: Daty from may 2019 till august 2023
Defined by ECMO registry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Results publication: PubMed 39360891Durila M, Vajter J, Garaj M, Berousek J, Lischke R, Hlavacek M, Vymazal T. Intravenous enoxaparin guided by anti-Xa in venovenous extracorporeal membrane oxygenation: A retrospective, single-center study. Artif Organs. 2025 Mar;49(3):486-496. doi: 10.1111/aor.14879. Epub 2024 Oct 3.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Miroslav Durila, prof. principal investigator
Department of anesthesiology and intensive care medicine, Motol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Respiratory Failure, run by University Hospital, Motol at 1 site 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 5 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: finished, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major bleeding complications (time frame: Daty from may 2019 till august 2023). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010446, which also lists 1 linked publication.
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 25 Feb 2025.