NCT01537263

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

February 15, 2012

Last Update Submit

April 5, 2012

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

Aneurysmal Subarachnoid HemorrhageSABSAHUltrasoundPerfusion imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Correlation between perfusion parameters, clinical course and flow velocities

    Day 1 to 90

  • Change of Perfusion

    Baseline, Day 5

Study Arms (1)

Ultrasound Perfusion Imaging

Patient with subarachnoid hemorrhage.

Device: Ultrasound Perfusion Imaging

Interventions

Ultrasound Perfusion ImagingDEVICE

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

Ultrasound Perfusion Imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Asklepios Hospital North

Hamburg, Hamburg, 22417, Germany

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Günter Seidel, MD, Professor of Neurology

    Asklepios Kliniken Hamburg GmbH

    STUDY DIRECTOR

Central Study Contacts

Günter Seidel, MD, Professor of Neurology

CONTACT

0049(0)401818873076g.seidel@asklepios.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor of Neurology

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 23, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

DE(1)