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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05554055
Acronym
AXAES
Enrollment
0
Registered
2022-09-26
Start date
2022-11-30
Completion date
2024-11-30
Last updated
2025-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Diseases, Arterial Disease, Thrombosis

Keywords

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

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.

Interventions

BIOLOGICALAnti 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Correlation between ACT (second) realized in operative room and Anti Xa activity (UI/ml) results provide by the lab.During surgery - 1 dayFollowing 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026