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

September 21, 2022 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bron, France, 69500
        • Service de chirurgie vasculaire (U50) Hôpital Louis Pradel - HCL
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between ACT (second) realized in operative room and Anti Xa activity (UI/ml) results provide by the lab.
Time Frame: 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.
During surgery - 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2022

Primary Completion (ANTICIPATED)

November 1, 2024

Study Completion (ANTICIPATED)

November 1, 2024

Study Registration Dates

First Submitted

September 21, 2022

First Submitted That Met QC Criteria

September 21, 2022

First Posted (ACTUAL)

September 26, 2022

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL22_0104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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