Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage (PSAB)

April 5, 2012 updated by: Gunter Seidel, MD, Asklepios Kliniken Hamburg GmbH
The purpose of this study is to examine wether delayed cerebral ischemia can be predicted by ultrasound brain perfusion imaging in patients with aneurysmal subarachnoid hemorrhage (SAH).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The delayed cerebral ischemia is a main complication in patient with aneurysmal subarachnoid hemorrhage which causes neurological deficit. So far there is no reliable diagnostic tool to predict the appearance of cerebral ischemia.

The causal correlation between presence of cerebral vasospasm measured daily by transcranial Doppler sonography (TCD) and occurrence of cerebral ischemia detected by cranial computed tomography scan (CCT) is not finally verified.

First studies demonstrated that ultrasound perfusion imaging (UPI) allows the detection of perfusion deficits in middle cerebral artery infarction.

The purpose of our study is to evaluate the diagnostic and prognostic value of UPI to predict delayed cerebral ischemia. In our trial we compare parameters of UPI (b= rise rate, A= plateau of acoustic intensity) in patients with aneurysmal subarachnoid hemorrhage with results of follow-up cranial computed tomography scans (CCT), TCD results and clinical outcome.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

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

Study Contact

  • Name: Günter Seidel, MD, Professor of Neurology
  • Phone Number: 0049(0)401818873076
  • Email: g.seidel@asklepios.com

Study Locations

  • Germany
      • Hamburg, Germany, 22417
        • Recruiting
        • Department of Neurology, Asklepios Hospital North
        • Contact:

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

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Aneurysmal subarachnoid hemorrhage, Hunt and Hess 0-5
  • Informed consent
  • Sufficient transtemporal acoustic window
  • First examination within 48h after subarachnoid hemorrhage
  • Minimum Age 18 years

Exclusion Criteria:

  • Contraindication against computed tomographic scan
  • Incompatibility against SonoVue™
  • Acute respiratory distress syndrome
  • Uncontrollable hypertensive crisis
  • Severe pulmonary disease(pulmonary hypertension > 90 mmHg)
  • acute severe cardiac insufficiency (New York Heart Association IV)
  • known right-left-shunt
  • pregnancy and breastfeeding
  • Substance dependence

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasound Perfusion Imaging
Patient with subarachnoid hemorrhage.
Device: Ultrasound Perfusion Imaging
Sonographic unit Phillips IU 22, 5ml SonoVue ultrasound contrast agent per examination, Duration: 1h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of perfusion
Time Frame: Baseline, Day 5
Detection of hypoperfusion (defined by 50% or more reduction in beta-value of comparing day 1. with day 5.) in one or more of four regions in one or both hemispheres before the detection of delayed ischemia after SAH in CCT.
Baseline, Day 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between perfusion parameters, clinical course and flow velocities
Time Frame: Day 1 to 90
Correlation between perfusion parameters (beta- and A-value), clinical course (National Institute of Health Stroke Scale - NIHSS) and flow velocities in the middle and posterior cerebral artery from day 1 to day 90.
Day 1 to 90
Change of Perfusion
Time Frame: Baseline, Day 5
Detection of hypoperfusion (defined by 50% or more reduction in A-value of comparing day 1. with day 5.) in one or more of four regions in one or both hemispheres before the detection of delayed ischemia after SAH in CCT.
Baseline, Day 5

Collaborators and Investigators

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

Sponsor

Asklepios Kliniken Hamburg GmbH

Investigators

  • Study Director: Günter Seidel, MD, Professor of Neurology, Asklepios Kliniken Hamburg GmbH

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

January 1, 2012

Primary Completion (Anticipated)

January 1, 2014

Study Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

February 17, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 5, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2371

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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