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

NCT02397759 | Unknown

• 2 other identifiers: 2012-542013-A00184-41
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage (SAH) From Ruptured Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• occurrence of vasopasm

  3 years

Study Arms (3)

Patients with severe SAH and vasospasm

EXPERIMENTAL

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

Patients with severe SAH without vasospasm

EXPERIMENTAL

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

Patients with severe SAH without external ventricular derivati

ACTIVE COMPARATOR

Patients with severe severe SAH from ruptured aneurysm without necessitating a EVD subarachnoid hemorrhage

Other: Blood draw and cerebrospinal fluid draw

Interventions

Blood draw and cerebrospinal fluid draw OTHER

Patients with severe SAH and vasospasm; Patients with severe SAH without external ventricular derivati; Patients with severe SAH without vasospasm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients presenting an infectious or carcinologic meningitis

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Hôpiital de la TIMONE ASSISTANCE PUBLIQUE HOPITAUX de MARSEILLE

Marseille, 13354, France

RECRUITING

Related Publications (2)

• Chikh K, Tonon D, Triglia T, Lagier D, Buisson A, Alessi MC, Defoort C, Benatia S, Velly LJ, Bruder N, Martin JC. Early Metabolic Disruption and Predictive Biomarkers of Delayed-Cerebral Ischemia in Aneurysmal Subarachnoid Hemorrhage. J Proteome Res. 2024 Jan 5;23(1):316-328. doi: 10.1021/acs.jproteome.3c00575. Epub 2023 Dec 26.

  PMID: 38148664 DERIVED

• 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.

  PMID: 27355865 DERIVED

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Urielle DESALBRES

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Central Study Contacts

Thibaut TRIGLIA

CONTACT

+33491329460; thibaut.triglia@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: November 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

FR (1)