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CompletedNCT06010446Updated Feb 25, 2025

Intravenous Continuous LMWH Seems to Be Safe Alternative to UFH in VV ECMO Patients

An observational study in Refractory Respiratory Failure, sponsored by University Hospital, Motol. Completed at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-25.

Sponsored by University Hospital, Motol · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
43
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Refractory Respiratory Failure
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 43 is below the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

University Hospital, Motol is the lead sponsor of 45 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with respiratory failure put VV ECMO

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
43 participants (actual)
Patient registry
No

Interventions

  • OtherNo intervention, just retrospective analysis of data.
06

What researchers measure

Primary outcomes

  1. Incidence of major bleeding complications

    Defined by ECMO registry

    Time frame: Daty from may 2019 till august 2023

  2. Incidence of major thrombotic complications

    Defined by ECMO registry

    Time frame: Daty from may 2019 till august 2023

  3. Incidence of major neurologic complications

    Defined by ECMO registry

    Time frame: Daty from may 2019 till august 2023

07

Study locations

1 site
  • Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care
    Prague, 150 06, Czechia
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06010446
Lead sponsor
University Hospital, Motol
Responsible party
Durila Miroslav MUDr. Ph.D. (prof.MD. Miroslav Durila, Ph.D., MHA, University Hospital, Motol) — Principal investigator
First posted
Aug 24, 2023
Start date
May 15, 2019
Primary completion
Aug 15, 2023
Completion
Aug 15, 2023
Last update
Feb 25, 2025

Study contacts

Miroslav Durila, prof.
principal investigator · Department of anesthesiology and intensive care medicine, Motol Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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