Metabolomic Profile and Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospas in Arterial Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Primary Purpose
Subarachnoid Hemorrhage (SAH) From Ruptured Aneurysm
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood draw and cerebrospinal fluid draw
Sponsored by
About this trial
This is an interventional diagnostic trial for Subarachnoid Hemorrhage (SAH) From Ruptured Aneurysm
Eligibility Criteria
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
Sites / Locations
- Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLERecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Patients with severe SAH and vasospasm
Patients with severe SAH without vasospasm
Patients with severe SAH without external ventricular derivati
Arm Description
Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) and presenting vasospasm
Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) without vasospasm
Patients with severe severe SAH from ruptured aneurysm without necessitating a EVD subarachnoid hemorrhage
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02397759
First Posted
March 20, 2015
Last Updated
March 20, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02397759
Brief Title
Metabolomic Profile and Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospas in Arterial Vasospasm After Aneurysmal Subarachnoid Hemorrhage
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage (SAH) From Ruptured Aneurysm
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with severe SAH and vasospasm
Arm Type
Experimental
Arm Description
Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) and presenting vasospasm
Arm Title
Patients with severe SAH without vasospasm
Arm Type
Experimental
Arm Description
Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) without vasospasm
Arm Title
Patients with severe SAH without external ventricular derivati
Arm Type
Active Comparator
Arm Description
Patients with severe severe SAH from ruptured aneurysm without necessitating a EVD subarachnoid hemorrhage
Intervention Type
Other
Intervention Name(s)
Blood draw and cerebrospinal fluid draw
Primary Outcome Measure Information:
Title
biomarkers iendtification of vasospasm
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
occurrence of vasopasm
Description
It will be study in the blood and CSF association between matrix metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thibaut TRIGLIA
Phone
+33491329460
Email
thibaut.triglia@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLE
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thibaut TRIGLIA, MD
Email
thibaut.triglia@ap-hm.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
27355865
Citation
Triglia T, Mezzapesa A, Martin JC, Verdier M, Lagier D, Dufour H, Bruder N, Alessi MC, Velly LJ. Early matrix metalloproteinase-9 concentration in the first 48 h after aneurysmal subarachnoid haemorrhage predicts delayed cerebral ischaemia: An observational study. Eur J Anaesthesiol. 2016 Sep;33(9):662-9. doi: 10.1097/EJA.0000000000000494.
Results Reference
derived
Learn more about this trial
Metabolomic Profile and Proteasic Activity as Biomarkers for Early Detection of Arterial Vasospas in Arterial Vasospasm After Aneurysmal Subarachnoid Hemorrhage
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