NCT04042571

Brief Summary

Transcranial Doppler ultrasound (TCD) monitoring and CT-scanner perfusion are useful but imperfect tools to identify vasospasm and allow intervention to avoid infarction. Permanent monitoring of cerebral tissue oximetry (rSO2) by NIRS, a noninvasive method could allow better vasospasm detection. This study will evaluate diagnostic accuracy of cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

July 31, 2019

Last Update Submit

July 22, 2025

Conditions

Subarachnoid Hemorrhage

Keywords

Intracranial oxymetrySubarachnoid HemorrhageVasospasm

Outcome Measures

Primary Outcomes (1)

  • Permanent measurement of cerabral oxymetry (rSO2) by NIRS system

    Difference between NIRS basal measurement entre la mesure basale du NIRS (NIRS average on the first hour of recording respectively on the left and right) and the NIRS measurement during the follow-up (lowest mean NIRS observed over one hour in patients without vasospasm diagnosed by the reference test or mean NIRS observed over the hour.

    From day 4 to day 12 post aneurysmal subarachnoid hemorrhage

Secondary Outcomes (4)

  • Severity of angiographic spasm

    Day 8 post aneurysmal subarachnoid hemorrhage

  • Pti02 value

    Day 4 post aneurysmal subarachnoid hemorrhage

  • Pti02 value

    Day 8 post aneurysmal subarachnoid hemorrhage

  • Pti02 value

    Day 12 post aneurysmal subarachnoid hemorrhage

Study Arms (1)

Cerebral oxymetry monitoring (NIRS)

EXPERIMENTAL

Cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools

Device: Cerebral oxymetry monitoring (NIRS)

Interventions

Cerebral oxymetry monitoring (NIRS)DEVICE

Near-InfraRed Spectroscopy (NIRS) is a non-invasive method measuring tissue oxygenation by regional saturation of capillary-oxygenated hemoglobin (rSO2). Starting on day 4 after aneurismal rupture NIRS electrods will be placed and maintained until day 12 permanently and blindly recording rSO2. Patients will be monitored following daily practice recommandations inclunding vasospasm detection and treatment.

Cerebral oxymetry monitoring (NIRS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women
  • Age ≥ 18 years
  • HSA "severe" defined according to the WFNS ≥ III
  • Intubated-ventilated patient or any other reason preventing a contributing neurological examination
  • Affiliate or beneficiary of a social security scheme
  • Free, informed and written consent signed by the representative

You may not qualify if:

  • Age \<18 years
  • Significant vasospasm as soon as the detection was detected on the initial imaging
  • Possible Neurological Surveillance
  • Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics
  • Intra-parenchymal frontal haematoma limiting the quality of measurement, diagnosed on imaging (Less than 25mm deep from the skin)
  • Patient in limitation of active therapeutics or with high probability of soon limitation of active therapeutics
  • Adhesive allergy to measuring patches
  • Patient under guardianship or safeguard of justice
  • Refusal of legal representative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33 076, France

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 2, 2019

Study Start

October 1, 2019

Primary Completion

December 24, 2022

Study Completion

December 30, 2022

Last Updated

July 24, 2025

Record last verified: 2025-07

Locations

FR(1)