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

NCT05554055 | Withdrawn

• 1 other identifier: 69HCL22_0104
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Diseases; Arterial Disease; Thrombosis

Keywords

Complex aortic endovascular repair; Arterial recanalization; Deep veinous recanalization; Anti Xa; LR-ACT; Heparin; Endovascular procedures

Outcome Measures

Primary Outcomes (1)

• Correlation between ACT (second) realized in operative room and Anti Xa activity (UI/ml) results provide by the lab.

  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.

  During surgery - 1 day

Interventions

Anti Xa activity measurement. BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who will undergo an endovascular surgery in the centre.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

MeSH Terms

Conditions

Aortic Diseases; Thrombosis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)