Back to resultsDeterminants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage
Primary Purpose
Ischemia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CerebroSpinal fluid and plasma samples
Sponsored by
About this trial
This is an interventional basic science trial for Ischemia focused on measuring cerebral ischemia
Eligibility Criteria
Inclusion Criteria:
Group 1 : • Patients who presented a ruptured aneurysm by aneurysmal subarachnoid hemorrhage (SAH) older than 72 hours. Diagnosis of SAH was confirmed by computed tomography, magnetic resonance imaging (MRI) or lumbar puncture as recommended
- symptomatic aneurysm treated with endovascular,
- Absence of achieving a lumbar puncture,
- Patients affiliated to a social security scheme,
- Patients who have given their free and informed consent and signed the consent or consent of the family.
Group 2 :
healthy volunteers with cerebrospinal fluid sample
Exclusion Criteria:
- Patients with no readable acoustic temporal bone window
- Patients with previous disease that might impair cerebral autoregulation (e.g., carotid stenosis, history of stroke or head injury).
Sites / Locations
- University Hospital of Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with subarachnoid hemorrhage
Control subjects
Arm Description
Patients with subarachnoid hemorrhage will have CerebroSpinal fluid and plasma sample.
healthy controls from a previous study with a CerebroSpinal fluid and plasma sample
Outcomes
Primary Outcome Measures
delayed cerebral ischemia
DCI was confirmed by CT or MR imaging
Secondary Outcome Measures
Full Information
NCT ID
NCT02829398
First Posted
July 4, 2016
Last Updated
May 10, 2017
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT02829398
Brief Title
Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage
Official Title
Hemodynamic and Biochemical Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The risk of delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) is associated with large cerebral artery vasospasm, but vasospasm is not a strong predictor for DCI. Assessment of cerebral autoregulation with transcranial Doppler (TCD) may improve the prediction of DCI. The aim of this prospective study was to assess the value of TCD-derived variables to be used alone or in combination for prediction of DCI
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemia
Keywords
cerebral ischemia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with subarachnoid hemorrhage
Arm Type
Experimental
Arm Description
Patients with subarachnoid hemorrhage will have CerebroSpinal fluid and plasma sample.
Arm Title
Control subjects
Arm Type
Active Comparator
Arm Description
healthy controls from a previous study with a CerebroSpinal fluid and plasma sample
Intervention Type
Procedure
Intervention Name(s)
CerebroSpinal fluid and plasma samples
Intervention Description
CerebroSpinal fluid and plasma samples for biological markers
Primary Outcome Measure Information:
Title
delayed cerebral ischemia
Description
DCI was confirmed by CT or MR imaging
Time Frame
inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Group 1 : • Patients who presented a ruptured aneurysm by aneurysmal subarachnoid hemorrhage (SAH) older than 72 hours. Diagnosis of SAH was confirmed by computed tomography, magnetic resonance imaging (MRI) or lumbar puncture as recommended
symptomatic aneurysm treated with endovascular,
Absence of achieving a lumbar puncture,
Patients affiliated to a social security scheme,
Patients who have given their free and informed consent and signed the consent or consent of the family.
Group 2 :
healthy volunteers with cerebrospinal fluid sample
Exclusion Criteria:
Patients with no readable acoustic temporal bone window
Patients with previous disease that might impair cerebral autoregulation (e.g., carotid stenosis, history of stroke or head injury).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
LARRUE Vincent, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25716738
Citation
Calviere L, Nasr N, Arnaud C, Czosnyka M, Viguier A, Tissot B, Sol JC, Larrue V. Prediction of Delayed Cerebral Ischemia After Subarachnoid Hemorrhage Using Cerebral Blood Flow Velocities and Cerebral Autoregulation Assessment. Neurocrit Care. 2015 Oct;23(2):253-8. doi: 10.1007/s12028-015-0125-x.
Results Reference
result
Learn more about this trial
Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage
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