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Completed

NCT Number: NCT06010446

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care

Prague, 150 06, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention, just retrospective analysis of data.

Other

Primary outcomes

  1. Incidence of major bleeding complications

    Time frame: Daty from may 2019 till august 2023

    Defined by ECMO registry

  2. Incidence of major thrombotic complications

    Time frame: Daty from may 2019 till august 2023

    Defined by ECMO registry

  3. Incidence of major neurologic complications

    Time frame: Daty from may 2019 till august 2023

    Defined by ECMO registry

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Registry information

Official study title

Intravenous Continuous LMWH (Enoxaparin) Seems to be Safe Alternative to UFH in Patients With VV ECMO

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2023
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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