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Trials / Completed

CompletedNCT06010446

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
43 (actual)
Sponsor
University Hospital, Motol · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERNo intervention, just retrospective analysis of data.

Timeline

Start date
2019-05-15
Primary completion
2023-08-15
Completion
2023-08-15
First posted
2023-08-24
Last updated
2025-02-25

Locations

1 site across 1 country: Czechia

Source: ClinicalTrials.gov record NCT06010446. Inclusion in this directory is not an endorsement.