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

Thrombosis Clinical Trial

— AXAES  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05554055
• Other study ID #: 69HCL22_0104
• Status: Not yet recruiting
• Start date: November 2022
• Est. completion date: November 2024

Study information

• Verified date: September 2022
• Source: Hospices Civils de Lyon
• Contact: Marine BORDET, Surgical Resident
• Phone: 0472117676
• Email: marine.bordet[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Diseases
• Arterial Disease
• Thrombosis

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
France	Service de chirurgie vasculaire (U50) Hôpital Louis Pradel - HCL	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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