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Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage (PSAB)

This study is currently recruiting participants.
Verified April 2012 by Asklepios Kliniken Hamburg GmbH
Sponsor:
Information provided by (Responsible Party):
Gunter Seidel, MD, Asklepios Kliniken Hamburg GmbH
ClinicalTrials.gov Identifier:
NCT01537263
First received: February 15, 2012
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention
Aneurysmal Subarachnoid Hemorrhage
 Device: Ultrasound Perfusion Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage

Further study details as provided by Asklepios Kliniken Hamburg GmbH:

Primary Outcome Measures:
  • Change of perfusion [ Time Frame: Baseline, Day 5 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Correlation between perfusion parameters, clinical course and flow velocities [ Time Frame: Day 1 to 90 ] [ Designated as safety issue: No ]
    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.

  • 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.


Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537263

Contacts
Contact: Günter Seidel, MD, Professor of Neurology 0049(0)401818873076 g.seidel@asklepios.com

Locations
Germany
Department of Neurology, Asklepios Hospital North Recruiting
Hamburg, Germany, 22417
Contact: Günter Seidel, MD, Professor of Neurology     0049(0)40 1818873076     g.seidel@asklepios.com    
Sponsors and Collaborators
Asklepios Kliniken Hamburg GmbH
Investigators
Study Director: Günter Seidel, MD, Professor of Neurology Asklepios Kliniken Hamburg GmbH
  More Information

No publications provided

Responsible Party: Gunter Seidel, MD, MD, Professor of Neurology, Asklepios Kliniken Hamburg GmbH
ClinicalTrials.gov Identifier: NCT01537263     History of Changes
Other Study ID Numbers: 2371
Study First Received: February 15, 2012
Last Updated: April 5, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Asklepios Kliniken Hamburg GmbH:
Aneurysmal Subarachnoid Hemorrhage
SAB
SAH
Ultrasound
Perfusion imaging

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013