Clinical trial NCT06010446: Intravenous Continuous LMWH Seems to Be Safe Alternative to UFH in VV ECMO Patients
Official title: Intravenous Continuous LMWH (enoxaparin) Seems to Be Safe Alternative to UFH in Patients with VV ECMO
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Respiratory Failure
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with respiratory failure put VV ECMO

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of major bleeding complications
timeFrame: Daty from may 2019 till august 2023
measure: Incidence of major thrombotic complications
timeFrame: Daty from may 2019 till august 2023
measure: Incidence of major neurologic complications
timeFrame: Daty from may 2019 till august 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care
Study officials:
affiliation: Department of anesthesiology and intensive care medicine, Motol Hospital
name: Miroslav Durila, prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.