Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (Anti Xa vs ACT-LR in Endovascular Surgery) (AXAES)
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
Conditions
Intervention / Treatment
Study Type
Contacts and Locations
Study Locations
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Bron, France, 69500
- Service de chirurgie vasculaire (U50) Hôpital Louis Pradel - HCL
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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