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

Completed

• Conditions: Refractory Respiratory Failure

• Registration Number: NCT06010446
• Lead Sponsor: University Hospital, Motol

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.

Study Timeline

• Study Start: 2019-05-15
• Primary Completion: 2023-08-15
• Study Completion: 2023-08-15
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-23
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of major bleeding complications	Daty from may 2019 till august 2023	Defined by ECMO registry
Incidence of major thrombotic complications	Daty from may 2019 till august 2023	Defined by ECMO registry
Incidence of major neurologic complications	Daty from may 2019 till august 2023	Defined by ECMO registry

Trial Locations

Locations (1)

Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care; 🇨🇿 Prague, Czechia