Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage

May 10, 2017 updated by: University Hospital, Toulouse

Hemodynamic and Biochemical Determinants of Vasospasm and Delayed Ischemic Deficits in Aneurysmal Subarachnoid Hemorrhage

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • University Hospital of Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with subarachnoid hemorrhage
Patients with subarachnoid hemorrhage will have CerebroSpinal fluid and plasma sample.
Procedure: CerebroSpinal fluid and plasma samples
CerebroSpinal fluid and plasma samples for biological markers
Active Comparator: Control subjects
healthy controls from a previous study with a CerebroSpinal fluid and plasma sample
Procedure: CerebroSpinal fluid and plasma samples
CerebroSpinal fluid and plasma samples for biological markers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
delayed cerebral ischemia
Time Frame: inclusion
DCI was confirmed by CT or MR imaging
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: LARRUE Vincent, MD, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

July 4, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07 304 02
  • Local Grant (Other Grant/Funding Number: 07 304 02)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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