Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Device: Ultrasound Perfusion Imaging

• Registration Number: NCT01537263
• Lead Sponsor: Asklepios Kliniken Hamburg GmbH

Brief Summary

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

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-02-17
• Study First Posted: 2012-02-23
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-05
• Last Update Posted: 2012-04-06
• Primary Completion: 2014-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound Perfusion Imaging	Ultrasound Perfusion Imaging	Patient with subarachnoid hemorrhage.

Primary Outcome Measures

Name	Time	Method
Change of perfusion	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.

Secondary Outcome Measures

Name	Time	Method
Change of Perfusion	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.
Correlation between perfusion parameters, clinical course and flow velocities	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.

Trial Locations

Locations (1)

Department of Neurology, Asklepios Hospital North; 🇩🇪 Hamburg, Germany