AneurysmANTICONEURORADNCT02848612
Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
An observational study of Aneurysm, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
To prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm
- What is being tested?
- anticoagulation by unfractionated heparin
- How many people
- 459 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2015to 15 Jul 2016
- 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: Patients over the age of 18 years undergoing one of the following interventional neuroradiology procedures at Amiens University Hospital: elective embolization of an intracranial aneurysm, emergency embolization of a ruptured intracranial aneurysm, elective or urgent embolization of an intracranial or perispinal arteriovenous malformation.
Who may be able to join
- Patients over the age of 18 years undergoing one of the following interventional neuroradiology procedures at Amiens University Hospital: elective embolization of an intracranial aneurysm, emergency embolization of a ruptured intracranial aneurysm, elective or urgent embolization of an intracranial or perispinal arteriovenous malformation.
Who cannot join
- Patients in whom all modalities of monitoring of the efficacy of anticoagulation (laboratory tests and point-of-care tests) were not performed, incomplete embolization or radiological follow-up records.
- Patients presenting a contraindication to the administration of unfractionated heparin: history of heparin-induced thrombocytopenia or haemorrhagic coagulopathy (von Willebrand disease, haemophilia).
Trial locations and contacts
1 site in 1 country.
About this study
To prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. However, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. Furthermore, the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature.
Read the detailed description
Since the beginning of the 2000s, the reference treatment for the management of aneurysmal subarachnoid haemorrhage consists of interventional neuroradiology with coil embolization of the aneurysm. Although ensuring a better neurological prognosis than neurosurgical clipping, interventional neuroradiology exposes the patient to various risks: thromboembolic complications during or after embolization and re-rupture of the aneurysm during embolization. To prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. However, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. Furthermore, the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature.
- Conditions
- Aneurysm
- Being tested
- anticoagulation by unfractionated heparin
- Keywords
- anticoagulation, aneurysmal subarachnoid haemorrhage, interventional neuroradiology, coil embolization
- Medical subject headings
- Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anticoagulation by unfractionated heparinDrug
anticoagulation by unfractionated heparin
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between laboratory clotting tests and point-of-care clotting tests
evaluation of the correlation between laboratory clotting tests and point-of-care clotting tests performed on the Hemochron Junior® device.
care clotting tests and laboratory tests in the setting of intracranial
embolization.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start20 Nov 2015
- Primary completion15 Jul 2016
- Study completion15 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AneurysmStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Retrospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel LORNE, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02848612
- Sponsor's protocol ID
- RNI2015-13 Pr Lorne
- Acronym
- ANTICONEURORAD
- Status last verified
- Oct 2018
- First submitted
- 26 Jul 2016
- Last updated
- 12 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
- ClinicalTrials.gov ID
- NCT02848612
- Acronym / sponsor ID
- ANTICONEURORAD / RNI2015-13 Pr Lorne
- Conditions
- Aneurysm
- Keywords
- anticoagulation, aneurysmal subarachnoid haemorrhage, interventional neuroradiology, coil embolization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 20 Nov 2015 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Jul 2016 (actual)
- First posted
- 28 Jul 2016 (estimated)
- 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.
To prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. However, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. Furthermore, the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature.
Detailed description
Since the beginning of the 2000s, the reference treatment for the management of aneurysmal subarachnoid haemorrhage consists of interventional neuroradiology with coil embolization of the aneurysm. Although ensuring a better neurological prognosis than neurosurgical clipping, interventional neuroradiology exposes the patient to various risks: thromboembolic complications during or after embolization and re-rupture of the aneurysm during embolization. To prevent thromboembolic complications, the embolization procedure is performed under prophylactic unfractionated heparin, the efficacy of which is monitored by point-of- care testing according to international guidelines. However, these guidelines are based on limited scientific evidence and the ideal level of anticoagulation required has not been precisely defined. Furthermore, the correlation between the point-of- care tests used at Amiens University Hospital and the reference methods used in the laboratory varies considerably according to the available literature.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 years undergoing one of the following interventional neuroradiology procedures at Amiens University Hospital: elective embolization of an intracranial aneurysm, emergency embolization of a ruptured intracranial aneurysm, elective or urgent embolization of an intracranial or perispinal arteriovenous malformation.
Key inclusion criteria (1 listed)
- Patients over the age of 18 years undergoing one of the following interventional neuroradiology procedures at Amiens University Hospital: elective embolization of an intracranial aneurysm, emergency embolization of a ruptured intracranial aneurysm, elective or urgent embolization of an intracranial or perispinal arteriovenous malformation.
Key exclusion criteria (2 listed)
- Patients in whom all modalities of monitoring of the efficacy of anticoagulation (laboratory tests and point-of-care tests) were not performed, incomplete embolization or radiological follow-up records.
- Patients presenting a contraindication to the administration of unfractionated heparin: history of heparin-induced thrombocytopenia or haemorrhagic coagulopathy (von Willebrand disease, haemophilia).
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 |
|---|---|---|
| anticoagulation by unfractionated heparinanticoagulation by unfractionated heparin | Drug | – |
Primary outcome
correlation between laboratory clotting tests and point-of-care clotting tests
Time frame: 6 months
evaluation of the correlation between laboratory clotting tests and point-of-care clotting tests performed on the Hemochron Junior® device. care clotting tests and laboratory tests in the setting of intracranial embolization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
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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.
Emmanuel LORNE, MD, PhD principal investigator
CHU Amiens
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 Aneurysm, run by Centre Hospitalier Universitaire, Amiens 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 12 Oct 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 laboratory clotting tests and point-of-care clotting tests (time frame: 6 months). 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 12 Oct 2018.