NCT06010446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

4.3 years

First QC Date

August 15, 2023

Last Update Submit

February 23, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Incidence of major bleeding complications

    Defined by ECMO registry

    Daty from may 2019 till august 2023

  • Incidence of major thrombotic complications

    Defined by ECMO registry

    Daty from may 2019 till august 2023

  • Incidence of major neurologic complications

    Defined by ECMO registry

    Daty from may 2019 till august 2023

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with respiratory failure put VV ECMO

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care

Prague, 150 06, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 39360891BACKGROUND

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Miroslav Durila, prof.

    Department of anesthesiology and intensive care medicine, Motol Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.MD. Miroslav Durila, Ph.D., MHA

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 24, 2023

Study Start

May 15, 2019

Primary Completion

August 15, 2023

Study Completion

August 15, 2023

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations