Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage
Hemodynamic and Biochemical Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage
2 other identifiers
interventional
41
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 4, 2016
CompletedFirst Posted
Study publicly available on registry
July 12, 2016
CompletedMay 11, 2017
May 1, 2017
3.6 years
July 4, 2016
May 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
delayed cerebral ischemia
DCI was confirmed by CT or MR imaging
inclusion
Study Arms (2)
Patients with subarachnoid hemorrhage
EXPERIMENTALPatients with subarachnoid hemorrhage will have CerebroSpinal fluid and plasma sample.
Control subjects
ACTIVE COMPARATORhealthy controls from a previous study with a CerebroSpinal fluid and plasma sample
Interventions
CerebroSpinal fluid and plasma samples for biological markers
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Toulouse
Toulouse, 31000, France
Related Publications (1)
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.
PMID: 25716738RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LARRUE Vincent, MD
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2016
First Posted
July 12, 2016
Study Start
March 1, 2008
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
May 11, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share