Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol

NCT02848612 | Completed

• 1 other identifier: RNI2015-13 Pr Lorne
• Study Type: observational
• Target: 459
• Locations: 1 country
• Sites: 1

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.

Conditions

Aneurysm

Keywords

anticoagulation; aneurysmal subarachnoid haemorrhage; interventional neuroradiology; coil embolization

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Interventions

anticoagulation by unfractionated heparin DRUG

anticoagulation by unfractionated heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Aneurysm

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Emmanuel LORNE, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: November 20, 2015
• Primary Completion: July 15, 2016
• Study Completion: July 15, 2016
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

FR (1)