Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage

NCT ID: NCT01537263

Last Updated: 2012-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-01-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Aneurysmal Subarachnoid Hemorrhage

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ultrasound Perfusion Imaging

Patient with subarachnoid hemorrhage.

Ultrasound Perfusion Imaging

Intervention Type DEVICE

Sonographic unit Phillips IU 22, 5ml SonoVue ultrasound contrast agent per examination, Duration: 1h

Interventions

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Ultrasound Perfusion Imaging

Sonographic unit Phillips IU 22, 5ml SonoVue ultrasound contrast agent per examination, Duration: 1h

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asklepios Kliniken Hamburg GmbH

OTHER

Sponsor Role lead

Responsible Party

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Gunter Seidel, MD

MD, Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Günter Seidel, MD, Professor of Neurology

Role: STUDY_DIRECTOR

Asklepios Kliniken Hamburg GmbH

Locations

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Department of Neurology, Asklepios Hospital North

Hamburg, City state of Hamburg, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Günter Seidel, MD, Professor of Neurology

Role: CONTACT

0049(0)401818873076

Facility Contacts

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Günter Seidel, MD, Professor of Neurology

Role: primary

0049(0)40 1818873076

Other Identifiers

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2371

Identifier Type: -

Identifier Source: org_study_id

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