Subarachnoid Hemorrhage (SAH) From Ruptured Aneurysm Clinical Trial
Official title:
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
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.
| 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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLE | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| 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 |