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Trial record 13 of 194 for:    Hemorrhage AND SAH

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

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ClinicalTrials.gov Identifier: NCT02397759
Recruitment Status : Unknown
Verified March 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : March 25, 2015
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage (SAH) From Ruptured Aneurysm Other: Blood draw and cerebrospinal fluid draw Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : November 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Bleeding

Arm Intervention/treatment
Experimental: Patients with severe SAH and vasospasm
Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) and presenting vasospasm
Other: Blood draw and cerebrospinal fluid draw
Experimental: Patients with severe SAH without vasospasm
Patients with severe SAH from ruptured aneurysm requiring the establishment of an external ventricular derivation (EVD) without vasospasm
Other: Blood draw and cerebrospinal fluid draw
Active Comparator: Patients with severe SAH without external ventricular derivati
Patients with severe severe SAH from ruptured aneurysm without necessitating a EVD subarachnoid hemorrhage
Other: Blood draw and cerebrospinal fluid draw



Primary Outcome Measures :
  1. biomarkers iendtification of vasospasm [ Time Frame: 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 :
  1. occurrence of vasopasm [ Time Frame: 3 years ]
    It will be study in the blood and CSF association between matrix metalloproteinases (MMP) 2 and 9 and the occurrence of vasopasm



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397759


Contacts
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Contact: Thibaut TRIGLIA +33491329460 thibaut.triglia@ap-hm.fr

Locations
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France
Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLE Recruiting
Marseille, France, 13354
Contact: Thibaut TRIGLIA, MD       thibaut.triglia@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hopitaux De Marseille

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02397759     History of Changes
Other Study ID Numbers: 2012-54
2013-A00184-41 ( Registry Identifier: Ansm )
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Aneurysm
Aneurysm, Ruptured
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases