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

Sponsor
University Hospital, Motol (Other)
Overall Status
Completed
CT.gov ID
NCT06010446
Collaborator
(none)
43
1
51
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention, just retrospective analysis of data.

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

Study Type:
Observational
Actual Enrollment :
43 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Intravenous Continuous LMWH (Enoxaparin) Seems to be Safe Alternative to UFH in Patients With VV ECMO
Actual Study Start Date :
May 15, 2019
Actual Primary Completion Date :
Aug 15, 2023
Actual Study Completion Date :
Aug 15, 2023

Outcome Measures

Primary Outcome Measures

  1. Incidence of major bleeding complications [Daty from may 2019 till august 2023]

    Defined by ECMO registry

  2. Incidence of major thrombotic complications [Daty from may 2019 till august 2023]

    Defined by ECMO registry

  3. Incidence of major neurologic complications [Daty from may 2019 till august 2023]

    Defined by ECMO registry

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care Prague Czechia 150 06

Sponsors and Collaborators

  • University Hospital, Motol

Investigators

  • Principal Investigator: Miroslav Durila, prof., Department of anesthesiology and intensive care medicine, Motol Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Durila Miroslav MUDr. Ph.D., prof.MD. Miroslav Durila, Ph.D., MHA, University Hospital, Motol
ClinicalTrials.gov Identifier:
NCT06010446
Other Study ID Numbers:
  • 15082023
First Posted:
Aug 24, 2023
Last Update Posted:
Aug 24, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2023