Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (Anti Xa vs ACT-LR in Endovascular Surgery)

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05554055

Collaborator

(none)

150

Enrollment

Location

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Activated clotting time (ACT) is currently recommended to monitor high concentrations heparin anticoagulation. ACT-LR was specifically designed to measure the activity of low dose of heparin used during endovascular surgery. The correlation between ACT-LR and Anti Xa activity which is considered as the gold standard seems to be debated.

Few studies in literature had shown controversial results. These studies were conducted in patients who underwent open as endovascular surgery. However, the ACT monitoring is not recommended in open surgery. In addition, heparin administration protocols are not described and specific to each centre.

In this study investigators want to study the correlation between LR-ACT and anti Xa after introducing a heparin protocol during complex endovascular procedures.

Condition or Disease	Intervention/Treatment	Phase
Aortic Diseases Arterial Disease Thrombosis	Biological: Anti Xa activity measurement.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures.

Anticipated Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Outcome Measures

Primary Outcome Measures

Correlation between ACT (second) realized in operative room and Anti Xa activity (UI/ml) results provide by the lab. [During surgery - 1 day]
Following the heparin administration protocol, each ACT measurement will be associated to a blood samples for anti Xa activity measurement. Retrospectively, anti Xa results will be analyze and compare to ACT value which will be report in the operative report. The blood samples will be taken in operative room during endovascular procedures as defined in the protocol.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 ans
Weight ≥ 37,5 kg
Patients operated for
complex endovascular aortic aneurysm repair
deep vein recanalization
complex arterial revascularization (TASC D lesions)
Patient informed of the study details and who didn't opposed to participate in this research

Exclusion Criteria:

Known allergy to heparin
Known hepatic insufficiency with repercussion on coagulation
Thrombocytopenia
Known hemostasis disorders
Anemia defined HB<8 g/L
Pregnant women
Persons deprived of their liberty by a judicial or administrative decision
Persons subject to psychiatric care
Persons admitted to a health or social establishment for purposes other than research
Adults subject to a legal protection measure (guardianship, curatorship)