Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (An… (NCT05554055) | Clinical Trial Compass
WithdrawnNot Applicable
Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (Anti Xa vs ACT-LR in Endovascular Surgery)
Stopped: The AXAES study was stopped mainly for logistical and organizational reasons. The machine needed to carry out the examinations was no longer available, making it impossible to continue the study.
France0Started 2022-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between ACT (second) realized in operative room and Anti Xa activity (UI/ml) results provide by the lab.