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

NCT ID: NCT06010446

Last Updated: 2025-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-15

Study Completion Date

2023-08-15

Brief Summary

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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

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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

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Refractory Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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No intervention, just retrospective analysis of data.

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Motol

OTHER

Sponsor Role lead

Responsible Party

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Durila Miroslav MUDr. Ph.D.

prof.MD. Miroslav Durila, Ph.D., MHA

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miroslav Durila, prof.

Role: PRINCIPAL_INVESTIGATOR

Department of anesthesiology and intensive care medicine, Motol Hospital

Locations

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Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care

Prague, , Czechia

Site Status

Countries

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Czechia

References

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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.

Reference Type BACKGROUND
PMID: 39360891 (View on PubMed)

Other Identifiers

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15082023

Identifier Type: -

Identifier Source: org_study_id

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