Overview

This trial is active, not recruiting.

Condition aneurysm
Treatment anticoagulation by unfractionated heparin
Sponsor Centre Hospitalier Universitaire, Amiens
Start date October 2015
End date April 2022
Trial size 412 participants
Trial identifier NCT02848612, RNI2015-13 Pr Lorne

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective

Primary Outcomes

Measure
correlation between laboratory clotting tests and point-of-care clotting tests
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
Principal investigator Emmanuel LORNE, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire, Amiens.