Subarachnoid HemorrhageNCT02907879
Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After SAH
An observational study of Subarachnoid Hemorrhage, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The objective of the study is to assess brain tissue perfusion by ultrasound perfusion imaging. Specifically to diagnose brain tissue hypoperfusion due to CVS with contrast enhanced UPI and to assess specificity and sensitivity, and predictive values for detection of brain tissue hypoperfusion leading to infarction to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 54 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to Apr 2021
- 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: All consecutive patients with aneurysmal SAH admitted to the Departments of Neurosurgery, Neurology, or Intensive Care Medicine, will be screened for enrollment in the study
Who may be able to join
- Proven SAH (CT or lumbar puncture)
- Proven aneurysm (digital subtraction angiography or CT-angiography)
- Age >18
- Informed consent of patient or relative
Who cannot join
- Pregnancy and breast feeding
- Acute coronary syndromes, severe ischemic heart disease (requiring revascularisation), severe aortic and mitral valve disease, severe congestive heart failure (NYHA >III/IV)
- Severe pulmonary or renal dysfunction
- Known allergy or adverse reaction to contrast material
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Neurosurgery, University Hospital Bern
Bern, 3010
About this study
Official title: Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After Subarachnoid Hemorrhage
The objective of the study is to assess brain tissue perfusion by ultrasound perfusion imaging. Specifically
- to diagnose brain tissue hypoperfusion due to CVS with contrast enhanced UPI and to assess specificity and sensitivity, and predictive values for detection of brain tissue hypoperfusion leading to infarction
- to test whether treatment-effects by induced hypertension, balloon-dilatation, or intra-arterial nimodipine infusion can be detected and quantified by UPI
Read the detailed description
The aim of the study is to assess brain tissue perfusion by ultrasound perfusion imaging (UPI).
The specific aim is to diagnose brain tissue hypoperfusion leading to infarction due to CVS with ultrasound perfusion imaging (UPI) and to correlate it with the gold standard of diagnosis of brain infarcts, i.e. with MRI and CT. According to contrast enhanced UPI brain tissue will be classified as (1) normal, i.e. not leading to tissue infarction, (2) as hypoperfused, i.e. functionally impaired and prone to DIND and to infarction, or (3) non-perfused. Thus, temporary hypoperfusion that may be resolved by therapy or spontaneously, not leading to tissue infarction shall be assessed. This strategy will lead to guiding therapy by UPI.
Questionnaire:
- to assess cerebral perfusion in patients with SAH by contrast enhanced UPI
- to assess specificity and sensitivity, as well as positive and negative predictive values of contrast enhanced UPI for detection of brain tissue misery perfusion leading to infarction
- to evaluate feasibility and practicability of repeated bed-side assessments of UPI
- to test whether treatment-effects like induced hypertension, balloon-dilation, or intra-arterial nimodipine infusion can be detected and quantified by contrast enhanced UPI
- to analyze whether TCD or contrast enhanced UPI is superior for screening of CVS and detection of cerebral infarcts (vessel vs. tissue assessment)
- to correlate contrast enhanced UPI with perfusion measurements by CT-perfusion imaging
Ultrasound perfusion imaging (UPI) is able to detect cerebral hypoperfusion that can result in cerebral infarction in a clinical setting. As reference the incidence of cerebral infarcts is assessed by CT- and MR-imaging and cerebral perfusion is analyzed by CT-perfusion (CTP) imaging.
The day of the ictus (SAH) is defined as day 0. The ultrasound examinations will be performed at
- Day 0-4: one baseline UPI study will be performed. This time period (0-4) is set as baseline, because this baseline investigation will be performed before vasospasm develops. The current policy of early aneurysm treatment results in clipping or coiling of patients within 24-48 hours. The relevant phase of CVS, however, starts on day 4 to 5 after the ictus. The already established routine protocol with early CT and CTP imaging after aneurysm treatment allows differentiation between infarcts due to the procedure of aneurysm clipping or coiling, bleeding, edema, or surgical contusions from cerebral infarcts due to CVS that develop later on. This early routine CT imaging includes a CT-perfusion study on post-op day 1, serving as reference for the ultrasound perfusion measurements.
- Day 5-14: during the term with the highest risk for CVS, a UPI study will be performed every second day.
- Several events trigger additional UPI studies:
- angiography (scheduled or emergency)
- endovascular intervention (angioplasty or intraarterial nimodipine infusion)
- CT or MRI study with new infarcts
- Development of DIND or reversal of DIND
- in case of placement of an intracerebral microprobe (rCBF or ptiO2) an UPI study will be performed when significant changes (rCBF drop below 20ml/100g/min or below 60% of baseline, ptiO2 drop below 10mmHg or below 60% of baseline) occur.
Currently all patients are scanned by MRI and or CT several times in the course of the disease. Each imaging study serves as reference for UPI.
During day 5-14 high risk patients (Fisher grade 3, or TCD > 150 cm/sec, or new deficit) receive one CT-perfusion study between day 7 and 11 (period of highest risk).
During day 5-14 patients with proven CVS (angiography) will receive two CT-perfusion studies, one at day 7, and one at day 11, or at the time when new deficits or infarcts evolve. Additional about 20% of patients will get MRI including perfusion weighted imaging (PWI). In these patients misery perfusion as detected by PWI serves as reference for UPI.
The actual UPI measurement takes place at the bedside, is performed by the study physician, and takes about 15 -30 minutes.
The trial duration per patient is 14 days during the initial hospitalization.
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Hemorrhage, Ultrasound perfusion imaging, cerebral hypoperfusion, vasospasm, DIND, infarction
- Medical subject headings
- Subarachnoid Hemorrhage, Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound perfusion imaging | Measuring methods of UPI with phase inversion harmonic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of cerebral hypoperfusion leading to either infarcts, neurological deficits, or initiation of rescue therapy
(1) normal, i.e. with a perfusion delay < 2 sec, (2) hypoperfusion, i.e. with a perfusion delay ≥ 2sec and < 6 sec, and (3) no perfusion, i.e. with a perfusion delay ≥ 6 sec as compared with the average of the 2 thalamic territories of the unaffected side
Measured: 14 days after ictus
Secondary outcomes (4)
Correlation between UPI parameters and cerebral perfusion as assessed by CT-perfusion
Measured: Within 14 days after ictus
Correlation between UPI parameters and cerebral perfusion as assessed by MRI-perfusion
Measured: Within 14 days after ictus
Correlation between UPI parameters and flow velocities in the middle cerebral artery as measured by TCD
Measured: Within 14 days after ictus
Correlation between UPI parameters with vessel diameters of the MCA as assessed by DSA
Measured: Within 14 days after ictus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startJul 2013
- Primary completionJan 2021
- Study completionApr 2021
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jürgen Beck, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907879
- Sponsor's protocol ID
- SONO SAB
- Status last verified
- Apr 2021
- First submitted
- 16 Sep 2016
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Reitmeir R, Eyding J, Oertel MF, Wiest R, Gralla J, Fischer U, Giquel PY, Weber S, Raabe A, Mattle HP, Z'Graggen WJ, Beck J. Is ultrasound perfusion imaging capable of detecting mismatch? A proof-of-concept study in acute stroke patients. J Cereb Blood Flow Metab. 2017 Apr;37(4):1517-1526. doi: 10.1177/0271678X16657574. Epub 2016 Jan 1.
PubMed 27389180de Rooij NK, Linn FH, van der Plas JA, Algra A, Rinkel GJ. Incidence of subarachnoid haemorrhage: a systematic review with emphasis on region, age, gender and time trends. J Neurol Neurosurg Psychiatry. 2007 Dec;78(12):1365-72. doi: 10.1136/jnnp.2007.117655. Epub 2007 Apr 30.
PubMed 17470467Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21.
PubMed 19233729Johnston SC, Selvin S, Gress DR. The burden, trends, and demographics of mortality from subarachnoid hemorrhage. Neurology. 1998 May;50(5):1413-8. doi: 10.1212/wnl.50.5.1413.
PubMed 9595997Weidauer S, Lanfermann H, Raabe A, Zanella F, Seifert V, Beck J. Impairment of cerebral perfusion and infarct patterns attributable to vasospasm after aneurysmal subarachnoid hemorrhage: a prospective MRI and DSA study. Stroke. 2007 Jun;38(6):1831-6. doi: 10.1161/STROKEAHA.106.477976. Epub 2007 Apr 19.
PubMed 17446425Vergouwen MD, Vermeulen M, Roos YB. Effect of nimodipine on outcome in patients with traumatic subarachnoid haemorrhage: a systematic review. Lancet Neurol. 2006 Dec;5(12):1029-32. doi: 10.1016/S1474-4422(06)70582-8.
PubMed 17110283Raabe A, Beck J, Keller M, Vatter H, Zimmermann M, Seifert V. Relative importance of hypertension compared with hypervolemia for increasing cerebral oxygenation in patients with cerebral vasospasm after subarachnoid hemorrhage. J Neurosurg. 2005 Dec;103(6):974-81. doi: 10.3171/jns.2005.103.6.0974.
PubMed 16381183Aaslid R, Huber P, Nornes H. Evaluation of cerebrovascular spasm with transcranial Doppler ultrasound. J Neurosurg. 1984 Jan;60(1):37-41. doi: 10.3171/jns.1984.60.1.0037.
PubMed 6689726Beck J, Raabe A, Lanfermann H, Seifert V, Weidauer S. Tissue at risk concept for endovascular treatment of severe vasospasm after aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1779-81. doi: 10.1136/jnnp.2004.036921.
PubMed 15548506Beck J, Raabe A, Lanfermann H, Seifert V, Weidauer S. Perfusion-weighted magnetic resonance imaging in patients with vasospasm: a useful new tool in the management of patients with subarachnoid hemorrhage. Neurosurgery. 2006 Mar;58(3):E590; author reply E590. doi: 10.1227/01.NEU.0000207963.98939.7B. No abstract available.
PubMed 16528172Eyding J, Krogias C, Schollhammer M, Eyding D, Wilkening W, Meves S, Schroder A, Przuntek H, Postert T. Contrast-enhanced ultrasonic parametric perfusion imaging detects dysfunctional tissue at risk in acute MCA stroke. J Cereb Blood Flow Metab. 2006 Apr;26(4):576-82. doi: 10.1038/sj.jcbfm.9600216.
PubMed 16121127Seidel G, Meyer-Wiethe K, Berdien G, Hollstein D, Toth D, Aach T. Ultrasound perfusion imaging in acute middle cerebral artery infarction predicts outcome. Stroke. 2004 May;35(5):1107-11. doi: 10.1161/01.STR.0000124125.19773.40. Epub 2004 Mar 18.
PubMed 15031454Chapman F, Morrissey R, McDermott S, Cahours X, Verron T, Taverner V, Stevenson M, Nahde T. Evaluation of high-nicotine oral products shows potential to reduce tobacco-related harm by offering satisfying alternatives. Sci Rep. 2025 Oct 3;15(1):34636. doi: 10.1038/s41598-025-21812-x.
PubMed 41044396Fung C, Heiland DH, Reitmeir R, Niesen WD, Raabe A, Eyding J, Schnell O, Rolz R, Z Graggen WJ, Beck J. Ultrasound Perfusion Imaging for the Detection of Cerebral Hypoperfusion After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2022 Aug;37(1):149-159. doi: 10.1007/s12028-022-01460-z. Epub 2022 Feb 24.
PubMed 35211837
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound Imaging for Cerebral Perfusion Measurement in Cerebral Vasospasm After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02907879
- Acronym / sponsor ID
- SONO SAB
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Subarachnoid Hemorrhage, Ultrasound perfusion imaging, cerebral hypoperfusion, vasospasm, DIND, infarction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 20 Sep 2016 (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 objective of the study is to assess brain tissue perfusion by ultrasound perfusion imaging. Specifically
- to diagnose brain tissue hypoperfusion due to CVS with contrast enhanced UPI and to assess specificity and sensitivity, and predictive values for detection of brain tissue hypoperfusion leading to infarction
- to test whether treatment-effects by induced hypertension, balloon-dilatation, or intra-arterial nimodipine infusion can be detected and quantified by UPI
Detailed description
The aim of the study is to assess brain tissue perfusion by ultrasound perfusion imaging (UPI).
The specific aim is to diagnose brain tissue hypoperfusion leading to infarction due to CVS with ultrasound perfusion imaging (UPI) and to correlate it with the gold standard of diagnosis of brain infarcts, i.e. with MRI and CT. According to contrast enhanced UPI brain tissue will be classified as (1) normal, i.e. not leading to tissue infarction, (2) as hypoperfused, i.e. functionally impaired and prone to DIND and to infarction, or (3) non-perfused. Thus, temporary hypoperfusion that may be resolved by therapy or spontaneously, not leading to tissue infarction shall be assessed. This strategy will lead to guiding therapy by UPI.
Questionnaire:
- to assess cerebral perfusion in patients with SAH by contrast enhanced UPI
- to assess specificity and sensitivity, as well as positive and negative predictive values of contrast enhanced UPI for detection of brain tissue misery perfusion leading to infarction
- to evaluate feasibility and practicability of repeated bed-side assessments of UPI
- to test whether treatment-effects like induced hypertension, balloon-dilation, or intra-arterial nimodipine infusion can be detected and quantified by contrast enhanced UPI
- to analyze whether TCD or contrast enhanced UPI is superior for screening of CVS and detection of cerebral infarcts (vessel vs. tissue assessment)
- to correlate contrast enhanced UPI with perfusion measurements by CT-perfusion imaging
Ultrasound perfusion imaging (UPI) is able to detect cerebral hypoperfusion that can result in cerebral infarction in a clinical setting. As reference the incidence of cerebral infarcts is assessed by CT- and MR-imaging and cerebral perfusion is analyzed by CT-perfusion (CTP) imaging.
The day of the ictus (SAH) is defined as day 0. The ultrasound examinations will be performed at
- Day 0-4: one baseline UPI study will be performed. This time period (0-4) is set as baseline, because this baseline investigation will be performed before vasospasm develops. The current policy of early aneurysm treatment results in clipping or coiling of patients within 24-48 hours. The relevant phase of CVS, however, starts on day 4 to 5 after the ictus. The already established routine protocol with early CT and CTP imaging after aneurysm treatment allows differentiation between infarcts due to the procedure of aneurysm clipping or coiling, bleeding, edema, or surgical contusions from cerebral infarcts due to CVS that develop later on. This early routine CT imaging includes a CT-perfusion study on post-op day 1, serving as reference for the ultrasound perfusion measurements.
- Day 5-14: during the term with the highest risk for CVS, a UPI study will be performed every second day.
- Several events trigger additional UPI studies:
- angiography (scheduled or emergency)
- endovascular intervention (angioplasty or intraarterial nimodipine infusion)
- CT or MRI study with new infarcts
- Development of DIND or reversal of DIND
- in case of placement of an intracerebral microprobe (rCBF or ptiO2) an UPI study will be performed when significant changes (rCBF drop below 20ml/100g/min or below 60% of baseline, ptiO2 drop below 10mmHg or below 60% of baseline) occur.
Currently all patients are scanned by MRI and or CT several times in the course of the disease. Each imaging study serves as reference for UPI.
During day 5-14 high risk patients (Fisher grade 3, or TCD > 150 cm/sec, or new deficit) receive one CT-perfusion study between day 7 and 11 (period of highest risk).
During day 5-14 patients with proven CVS (angiography) will receive two CT-perfusion studies, one at day 7, and one at day 11, or at the time when new deficits or infarcts evolve. Additional about 20% of patients will get MRI including perfusion weighted imaging (PWI). In these patients misery perfusion as detected by PWI serves as reference for UPI.
The actual UPI measurement takes place at the bedside, is performed by the study physician, and takes about 15 -30 minutes.
The trial duration per patient is 14 days during the initial hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound perfusion imaging | – | –Measuring methods of UPI with phase inversion harmonic imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients with aneurysmal SAH admitted to the Departments of Neurosurgery, Neurology, or Intensive Care Medicine, will be screened for enrollment in the study
Key inclusion criteria (4 listed)
- Proven SAH (CT or lumbar puncture)
- Proven aneurysm (digital subtraction angiography or CT-angiography)
- Age >18
- Informed consent of patient or relative
Key exclusion criteria (4 listed)
- Pregnancy and breast feeding
- Acute coronary syndromes, severe ischemic heart disease (requiring revascularisation), severe aortic and mitral valve disease, severe congestive heart failure (NYHA >III/IV)
- Severe pulmonary or renal dysfunction
- Known allergy or adverse reaction to contrast material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of cerebral hypoperfusion leading to either infarcts, neurological deficits, or initiation of rescue therapy
Time frame: 14 days after ictus
(1) normal, i.e. with a perfusion delay < 2 sec, (2) hypoperfusion, i.e. with a perfusion delay ≥ 2sec and < 6 sec, and (3) no perfusion, i.e. with a perfusion delay ≥ 6 sec as compared with the average of the 2 thalamic territories of the unaffected side
4 secondary outcomes
Correlation between UPI parameters and cerebral perfusion as assessed by CT-perfusion
Time frame: Within 14 days after ictus
Correlation between UPI parameters and cerebral perfusion as assessed by MRI-perfusion
Time frame: Within 14 days after ictus
Correlation between UPI parameters and flow velocities in the middle cerebral artery as measured by TCD
Time frame: Within 14 days after ictus
Correlation between UPI parameters with vessel diameters of the MCA as assessed by DSA
Time frame: Within 14 days after ictus
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Background: PubMed 27389180Reitmeir R, Eyding J, Oertel MF, Wiest R, Gralla J, Fischer U, Giquel PY, Weber S, Raabe A, Mattle HP, Z'Graggen WJ, Beck J. Is ultrasound perfusion imaging capable of detecting mismatch? A proof-of-concept study in acute stroke patients. J Cereb Blood Flow Metab. 2017 Apr;37(4):1517-1526. doi: 10.1177/0271678X16657574. Epub 2016 Jan 1.
- Background: PubMed 17470467de Rooij NK, Linn FH, van der Plas JA, Algra A, Rinkel GJ. Incidence of subarachnoid haemorrhage: a systematic review with emphasis on region, age, gender and time trends. J Neurol Neurosurg Psychiatry. 2007 Dec;78(12):1365-72. doi: 10.1136/jnnp.2007.117655. Epub 2007 Apr 30.
- Background: PubMed 19233729Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21.
- Background: PubMed 9595997Johnston SC, Selvin S, Gress DR. The burden, trends, and demographics of mortality from subarachnoid hemorrhage. Neurology. 1998 May;50(5):1413-8. doi: 10.1212/wnl.50.5.1413.
- Background: PubMed 17446425Weidauer S, Lanfermann H, Raabe A, Zanella F, Seifert V, Beck J. Impairment of cerebral perfusion and infarct patterns attributable to vasospasm after aneurysmal subarachnoid hemorrhage: a prospective MRI and DSA study. Stroke. 2007 Jun;38(6):1831-6. doi: 10.1161/STROKEAHA.106.477976. Epub 2007 Apr 19.
- Background: PubMed 17110283Vergouwen MD, Vermeulen M, Roos YB. Effect of nimodipine on outcome in patients with traumatic subarachnoid haemorrhage: a systematic review. Lancet Neurol. 2006 Dec;5(12):1029-32. doi: 10.1016/S1474-4422(06)70582-8.
- Background: PubMed 16381183Raabe A, Beck J, Keller M, Vatter H, Zimmermann M, Seifert V. Relative importance of hypertension compared with hypervolemia for increasing cerebral oxygenation in patients with cerebral vasospasm after subarachnoid hemorrhage. J Neurosurg. 2005 Dec;103(6):974-81. doi: 10.3171/jns.2005.103.6.0974.
- Background: PubMed 6689726Aaslid R, Huber P, Nornes H. Evaluation of cerebrovascular spasm with transcranial Doppler ultrasound. J Neurosurg. 1984 Jan;60(1):37-41. doi: 10.3171/jns.1984.60.1.0037.
- Background: PubMed 15548506Beck J, Raabe A, Lanfermann H, Seifert V, Weidauer S. Tissue at risk concept for endovascular treatment of severe vasospasm after aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2004 Dec;75(12):1779-81. doi: 10.1136/jnnp.2004.036921.
- Background: PubMed 16528172Beck J, Raabe A, Lanfermann H, Seifert V, Weidauer S. Perfusion-weighted magnetic resonance imaging in patients with vasospasm: a useful new tool in the management of patients with subarachnoid hemorrhage. Neurosurgery. 2006 Mar;58(3):E590; author reply E590. doi: 10.1227/01.NEU.0000207963.98939.7B. No abstract available.
- Background: PubMed 16121127Eyding J, Krogias C, Schollhammer M, Eyding D, Wilkening W, Meves S, Schroder A, Przuntek H, Postert T. Contrast-enhanced ultrasonic parametric perfusion imaging detects dysfunctional tissue at risk in acute MCA stroke. J Cereb Blood Flow Metab. 2006 Apr;26(4):576-82. doi: 10.1038/sj.jcbfm.9600216.
- Background: PubMed 15031454Seidel G, Meyer-Wiethe K, Berdien G, Hollstein D, Toth D, Aach T. Ultrasound perfusion imaging in acute middle cerebral artery infarction predicts outcome. Stroke. 2004 May;35(5):1107-11. doi: 10.1161/01.STR.0000124125.19773.40. Epub 2004 Mar 18.
- Individual participant dataSharing planned: Yes
Related trials for Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
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.
Jürgen Beck, MD principal investigator
Insel Gruppe AG, University Hospital Bern
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 Subarachnoid Hemorrhage, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 23 Apr 2021. 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 Switzerland. 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?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of cerebral hypoperfusion leading to either infarcts, neurological deficits, or initiation of rescue therapy (time frame: 14 days after ictus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02907879, which also lists 14 linked publications.
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 23 Apr 2021.