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

NCT ID: NCT05554055

Last Updated: 2025-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-30

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Diseases Arterial Disease Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Anti Xa activity measurement.

Arterial blood samples of 3cc will be taken during the procedure at each ACT. Blood samples will be sent to the lab for anti Xa activity measurement.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de chirurgie vasculaire (U50) Hôpital Louis Pradel - HCL

Bron, , France

Site Status

Countries

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France

Other Identifiers

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69HCL22_0104

Identifier Type: -

Identifier Source: org_study_id

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