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NCT05554055 | Not yet recruiting | Aortic Diseases


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

Civil Hospices of 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.

Condition or disease

Aortic Diseases

Arterial Disease

Thrombosis

Intervention/treatment

Anti Xa activity measurement.

Study Type : Observational
Estimated Enrollment : 150 participants
Official Title : Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures.
Actual Study Start Date : November 2022
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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)

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

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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)

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Locations


Not yet recruiting

France,

Vascular surgery department (U50) Louis Pradel Hospital - HCL

Bron, France, 69500

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