Aneurysmal Subarachnoid HemorrhagePSABNCT01537263
Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Asklepios Kliniken Hamburg GmbH at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Ultrasound Perfusion Imaging
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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
Who cannot join
- 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)
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- known right-left-shunt
- pregnancy and breastfeeding
- Substance dependence
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, Asklepios Hospital North
Hamburg, Free and Hanseatic City of Hamburg, 22417
Günter Seidel, MD, Professor of Neurology, 0049(0)40 1818873076, g.seidel@asklepios.com
About this study
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).
Read the 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.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Ultrasound Perfusion Imaging
- Keywords
- Aneurysmal Subarachnoid Hemorrhage, SAB, SAH, Ultrasound, Perfusion imaging
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Perfusion ImagingDevice
Sonographic unit Phillips IU 22, 5ml SonoVue ultrasound contrast agent per examination, Duration: 1h
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Perfusion Imaging | Patient with subarachnoid hemorrhage. Receives: Device: Ultrasound Perfusion Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 5
Secondary outcomes (2)
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.
Measured: Day 1 to 90
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.
Measured: Baseline, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepios Kliniken Hamburg GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunter Seidel, MD, Asklepios Kliniken Hamburg GmbH
- Investigators
- Günter Seidel, MD, Professor of Neurology, Study director, Asklepios Kliniken Hamburg GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537263
- Sponsor's protocol ID
- 2371
- Acronym
- PSAB
- Status last verified
- Apr 2012
- First submitted
- 15 Feb 2012
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Perfusion Imaging After Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01537263
- Acronym / sponsor ID
- PSAB / 2371
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- Aneurysmal Subarachnoid Hemorrhage, SAB, SAH, Ultrasound, Perfusion imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Asklepios Kliniken Hamburg GmbHUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Perfusion Imaging | – | Device: Ultrasound Perfusion ImagingPatient with subarachnoid hemorrhage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Contraindication against computed tomographic scan
- Incompatibility against SonoVue™
- Acute respiratory distress syndrome
- Uncontrollable hypertensive crisis
- Severe pulmonary disease(pulmonary hypertension > 90 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Perfusion ImagingSonographic unit Phillips IU 22, 5ml SonoVue ultrasound contrast agent per examination, Duration: 1h | Device | Ultrasound Perfusion Imaging |
Primary outcome
Change of perfusion
Time frame: 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.
2 secondary outcomes
Correlation between perfusion parameters, clinical course and flow velocities
Time frame: Day 1 to 90
Change of Perfusion
Time frame: Baseline, Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Günter Seidel, MD, Professor of Neurology study director
Asklepios Kliniken Hamburg GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Asklepios Kliniken Hamburg GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Günter Seidel, MD, Professor of Neurology (0049(0)401818873076, g.seidel@asklepios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of perfusion (time frame: Baseline, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2012.