Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— PSAB  

Official title:

Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01537263
• Other study ID #: 2371
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2012
• Last updated: April 5, 2012
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: April 2012
• Source: Asklepios Kliniken Hamburg GmbH
• Contact: Günter Seidel, MD, Professor of Neurology
• Phone: 0049(0)401818873076
• Email: g.seidel[@]asklepios.com
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Device:
• Ultrasound Perfusion Imaging
Sonographic unit Phillips IU 22, 5ml SonoVue ultrasound contrast agent per examination, Duration: 1h

Locations

Country	Name	City	State
Germany	Department of Neurology, Asklepios Hospital North	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Asklepios Kliniken Hamburg GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of perfusion	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	No
Secondary	Correlation between perfusion parameters, clinical course and flow velocities	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	No
Secondary	Change of Perfusion	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