Metabolomic Profile and Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospas in Arterial Vasospasm After Aneurysmal Subarachnoid Hemorrhage

Not Applicable

• Conditions: Subarachnoid Hemorrhage (SAH) From Ruptured Aneurysm
• Interventions: Other: Blood draw and cerebrospinal fluid draw

• Registration Number: NCT02397759
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Status Verified: 2015-03
• Study First Submitted: 2015-03-20
• Study First Submitted QC: 2015-03-20
• Last Update Submitted: 2015-03-20
• Study First Posted: 2015-03-25
• Last Update Posted: 2015-03-25
• Primary Completion: 2016-11
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with severe SAH without external ventricular derivati	Blood draw and cerebrospinal fluid draw	Patients with severe severe SAH from ruptured aneurysm without necessitating a EVD subarachnoid hemorrhage
Patients with severe SAH without vasospasm	Blood draw and cerebrospinal fluid draw	Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) without vasospasm
Patients with severe SAH and vasospasm	Blood draw and cerebrospinal fluid draw	Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) and presenting vasospasm

Primary Outcome Measures

Name	Time	Method
biomarkers iendtification of vasospasm	3 years	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

Secondary Outcome Measures

Name	Time	Method
occurrence of vasopasm	3 years	It will be study in the blood and CSF association between matrix metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm

Trial Locations

Locations (1)

Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLE; 🇫🇷 Marseille, France