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

Refractory Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06010446
• Other study ID #: 15082023
• Status: Completed
• Start date: May 15, 2019
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Motol
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Refractory Respiratory Failure
• Respiratory Insufficiency

Intervention

Other:
• No intervention, just retrospective analysis of data.

Locations

Country	Name	City	State
Czechia	Unoversity Hospital Motol, Department of Anaesthesiology and Intensive Care	Prague

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of major bleeding complications	Defined by ECMO registry	Daty from may 2019 till august 2023
Primary	Incidence of major thrombotic complications	Defined by ECMO registry	Daty from may 2019 till august 2023
Primary	Incidence of major neurologic complications	Defined by ECMO registry	Daty from may 2019 till august 2023