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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02397759
Other study ID # 2012-54
Secondary ID 2013-A00184-41
Status Recruiting
Phase N/A
First received March 20, 2015
Last updated March 20, 2015
Start date November 2013
Est. completion date November 2017

Study information

Verified date March 2015
Source Assistance Publique Hopitaux De Marseille
Contact Thibaut TRIGLIA
Phone +33491329460
Email thibaut.triglia@ap-hm.fr
Is FDA regulated No
Health authority FRANCE: Agence Nationale de Sécurité du Médicament et des produits de
Study type Interventional

Clinical Trial Summary

The subarachnoid hemorrhage (SAH) from ruptured aneurysm is a situation that is life-threatening, which is largely dependent on the occurrence of vasospasm from the 4th day after the bleeding. This vasopasm is responsible of clinical morbidity in 30 to 50% of patients. It occurs in 40% of patients with severe SAH.

Despite knowing this, the clinician has no biomarker for identifying patients at risk.

The project presented is original and includes a screening method without a priori to identify predictive biomarkers of vasospasm, likely to become therapeutic targets. In secondary objective we will focus on the protease activity of cerebrospinal fluid (CSF) and blood as a biomarker potential of vasoconstriction at the waning of subarachnoid hemorrhage.

This study will take place over a year prospectively. The inclusion of patients will be in the SAR 1 Hospital of Timone. Patients with severe severe SAH by rupture requiring the establishment of an external ventricular derivation (EVD) will be divided into two groups and compared to one group of patients without necessitating a EVD subarachnoid hemorrhage.

- Group 1: Patients with vasopasm

- Group 2: Patient presenting no vasopasm Detection of vasopasm was defined using a consensual definition. CSF samples (through EVD) and blood will be made upon arrival of the patient in intensive care and then between the 3rd and 4th day.

As the main criterion, we will identify biomarkers of vasospasm in blood and CSF without a priori assumption by metabolomics. Analysis will be by chromatography system coupled to a high resolution mass spectrometer. This method does not justify effective calculation because it is a step of generating hypotheses requiring further biological validation based on the identified targets.

The secondary criteria, we will study in the blood and CSF association between matrix metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm.

RESULTS: After comparative analysis of groups 1 and 2 in two phases of the study, we will define a metabolic profile that could identify predictive biomarkers vasopasm.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with severe severe SAH by rupture requiring the establishment of an external ventricular derivation (EVD) will be divided into two groups

- Group 1: Patients with vasopasm

- Group 2: Patient presenting no vasopasm

Exclusion Criteria:

- Patients presenting an infectious or carcinologic meningitis

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Blood draw and cerebrospinal fluid draw


Locations

Country Name City State
France Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLE Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary biomarkers iendtification of vasospasm It will be identify biomarkers of vasospasm in blood and CSF without a priori assumption by metabolomics. Analysis will be by chromatography system coupled to a high resolution mass spectrometer 3 years No
Secondary occurrence of vasopasm It will be study in the blood and CSF association between matrix metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm 3 years No