Predictive Model for the Occurrence of Cerebral Vasospasm Complicating Subarachnoid Haemorrhage by Combined Analysis of the Kinetics of a Panel of Biomarkers.

NCT06303349 | Completed

• 1 other identifier: CHUBX 2023/45
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to create a dynamic clinical prediction model that includes routinely measured care and biological biomarkers to predict cerebral vasospasm within 14 days of bleeding in patients treated in the neurosurgical intensive care unit for subarachnoid hemorrhage. Patients admitted to intensive care will be followed for up to 14 days (D14 time horizon of interest), or until discharge from intensive care if earlier. Blood samples will be taken from D1 to D10 to isolate the blood biomarkers of interest for each patient. The measurement of biomarkers and cerebral vasospasm will be blinded to each other.

Conditions

Cerebral Vasospasm

Keywords

subarachnoid hemorrhage; Cerebral Vasospasm; biomarker; S100 β; IL-6; NSE

Outcome Measures

Primary Outcomes (1)

• Occurrence of cerebral vasospasm

  Occurrence of cerebral vasospasm within 14 days of ICU (Intensive Care Unit) admission.

  Day 14 after inclusion

Secondary Outcomes (15)

• Biomarkers measurements

  Day 10 after inclusion

• WFNS (World Federation of Neurologic Surgeons) score

  up to Day 10 after inclusion

• Glasgow score

  up to Day 10 after inclusion

• Medical Research Council (MRC) score

  up to Day 10 after inclusion

• PtiO2 (oxygen pressure in the cerebral tissue)

  up to Day 10 after inclusion

Study Arms (1)

experimental arm

EXPERIMENTAL

Patients with subarachnoid hemorrhage, whether aneurysmal or non-aneurysmal, who were admitted to the neuro-resuscitation unit within four days of onset. Diagnosis was based on clinical presentation and confirmed by brain imaging

Other: Samples collection

Interventions

Samples collection OTHER

from D1 to D10, 1 SSTII (Serum separator tubes II) dry tube of 6 mL blood and 1 EDTA (Ethylenediamine tetraacetic acid) tube of 6 mL blood are collected. 1 SSTII dry tube of 6 mL cerebral spinal fluid will be collected distally in external ventricular drain, after eliminating the dead volume of the collection burette, for patients with it.

experimental arm

Eligibility Criteria

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

You may qualify if:

• Subarachnoid hemorrhage (of aneurysmal or non-aneurysmal etiology) less than 4 days prior to admission to neuro-resuscitation, diagnosed on clinical presentation and confirmed by brain imaging.
• Free, informed and written consent signed by the patient (or, failing this, his or her representative).
• Patient entitled to or affiliated with social security

You may not qualify if:

• Significant vasospasm on admission to the department, diagnosed on initial imaging
• Patient whose short-term survival (48 hours) appears compromised
• Contraindication to perfusion CT scan
• Pregnant or breast-feeding women
• Patient under legal protection (persons deprived of liberty or under guardianship)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Vasospasm, Intracranial; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

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

Study Officials

• Grégoire CANE, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Hugues De COURSON, Dr

  University Hospital, Bordeaux

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-centre cohort study with prognostic aim, carried out in the neuro-resuscitation unit of the Bordeaux University Hospital.

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: May 7, 2024
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Locations

FR (1)