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Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol (ANTICONEURORAD)

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ClinicalTrials.gov Identifier: NCT02848612
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief 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. 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.

Condition or disease Intervention/treatment
Aneurysm Drug: anticoagulation by unfractionated heparin

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.

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Study Type : Observational
Actual Enrollment : 459 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
Actual Study Start Date : November 20, 2015
Actual Primary Completion Date : July 15, 2016
Actual Study Completion Date : July 15, 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: anticoagulation by unfractionated heparin
    anticoagulation by unfractionated heparin


Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848612


Locations
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France
CHU Amiens
Amiens, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Emmanuel LORNE, MD, PhD CHU Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02848612    
Other Study ID Numbers: RNI2015-13 Pr Lorne
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
anticoagulation
aneurysmal subarachnoid haemorrhage
interventional neuroradiology
coil embolization
Additional relevant MeSH terms:
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Aneurysm
Vascular Diseases
Cardiovascular Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action