Metabolomic Profile and Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospas in Arterial Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Analysis of Cerebral Spinal Fluid and Plasma After Aneurysmal Subarachnoid Hemorrhage by Evaluating a Metabolomic Profile and the Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospasm
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REGISTRY · Ansm
interventional
40
1 country
1
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Estimated enrollment
- 40 participants
- Study completion date
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Listed locations
- 1 countries · 1 sites
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
November 2013
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
March 20, 2015
Actual (reported)First Posted
March 25, 2015
Actual (reported)Primary Completion
November 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- March 25, 2015
- Status Verified
- March 2015
- Last Update Submitted
- March 20, 2015