Aortic DiseasesAXAESNCT05554055
Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (Anti Xa vs ACT-LR in Endovascular Surgery)
An observational study of Aortic Diseases and Arterial Disease, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Diseases, Arterial Disease, Thrombosis
- What is being tested?
- Anti Xa activity measurement.
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2022to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who will undergo an endovascular surgery in the centre.
Who may be able to join
- 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
Who cannot join
- Known allergy to heparin
- Known hepatic insufficiency with repercussion on coagulation
- Thrombocytopenia
- Known hemostasis disorders
- Anemia defined HB<8 g/L
- Pregnant women
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site
Service de chirurgie vasculaire (U50) Hôpital Louis Pradel - HCL
Bron, 69500
About this study
Official title: 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.
- Conditions
- Aortic Diseases, Arterial Disease, Thrombosis
- Being tested
- Anti Xa activity measurement.
- Keywords
- Complex aortic endovascular repair, Arterial recanalization, Deep veinous recanalization, Anti Xa, LR-ACT, Heparin, Endovascular procedures
- Medical subject headings
- Aortic Diseases, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti Xa activity measurement.Biological
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery - 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554055
- Sponsor's protocol ID
- 69HCL22_0104
- Acronym
- AXAES
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2022
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures.
- ClinicalTrials.gov ID
- NCT05554055
- Acronym / sponsor ID
- AXAES / 69HCL22_0104
- Conditions
- Aortic Diseases, Arterial Disease, Thrombosis
- Keywords
- Complex aortic endovascular repair, Arterial recanalization, Deep veinous recanalization, Anti Xa, LR-ACT, Heparin, Endovascular procedures
- Study type
- Observational
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who will undergo an endovascular surgery in the centre.
Key inclusion criteria (7 listed)
- Age ≥ 18 ans
- Weight ≥ 37,5 kg
- Patients operated for
- complex endovascular aortic aneurysm repair
- deep vein recanalization
Key exclusion criteria (10 listed)
- Known allergy to heparin
- Known hepatic insufficiency with repercussion on coagulation
- Thrombocytopenia
- Known hemostasis disorders
- Anemia defined HB<8 g/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | – |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Diseases and Arterial Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.