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

Not yet recruiting

• Conditions: Aortic Diseases; Arterial Disease; Thrombosis

• Registration Number: NCT05554055
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Last Update Submitted: 2022-09-21
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Study Start: 2022-11
• Primary Completion: 2024-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Service de chirurgie vasculaire (U50) Hôpital Louis Pradel - HCL; 🇫🇷 Bron, France