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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02848612
Other study ID # RNI2015-13 Pr Lorne
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 20, 2015
Est. completion date July 15, 2016

Study information

Verified date October 2018
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 459
Est. completion date July 15, 2016
Est. primary completion date July 15, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
anticoagulation by unfractionated heparin
anticoagulation by unfractionated heparin

Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 JuniorĀ® device.
care clotting tests and laboratory tests in the setting of intracranial
embolization.
6 months
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