Subarachnoid Aneurysm HemorrhageDecibelNCT07305922
Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension
An observational study of Subarachnoid Aneurysm Hemorrhage and Cerebral Vasospasm After Subarachnoid Hemorrhage, run by Region Stockholm at 1 site in Sweden.
Trial summary
An observational study of patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage, employing multimodal neuromonitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Aneurysm Hemorrhage, Cerebral Vasospasm After Subarachnoid Hemorrhage
- What is being tested?
- Induced hypertension with norepinephrine and Endoluminal Spasmolysis
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2025to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients treated for subarachnoid haemorrhage at the Intensive care unit at Karolinska University Hospital.
Who may be able to join
- Adults 18 years or older
- Critical care after subarachnoid haemorrhage
- Aneurysm secured by surgical clipping or endovascular procedure
- Suspected, emerging or established severe cerebral vasospasm
Who cannot join
- Anticipated survival less than five days, as determined by treating clinician
- Transcranial Doppler signal too weak
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 17176
Peter C Rudberg, M.D Ph.D., +46-8-12370000 ext. 72341, peter.rudberg@ki.se
About this study
An observational study of patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage, employing multimodal neuromonitoring.
- Being tested
- Induced hypertension with norepinephrine, Endoluminal Spasmolysis
- Keywords
- Transcranial Doppler, Endoluminal Spasmolysis, Induced Hypertension, Multimodal Neuromonitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced hypertension with norepinephrineDrug
Induced hypertension with norepinephrine and/or dobutamine to attain clinically established goals of cerebral perfusion pressure in a stepwise fashion, according to clinical routine.
Endoluminal SpasmolysisDrug
Endoluminal spasmolysis of cerebral arteries using i.a. Nimodipine, according to clinical protocol and neurointerventionist discretion.
| Study group | Role | What they receive |
|---|---|---|
| Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage | Not described Receives: Drug: Induced hypertension with norepinephrine; Drug: Endoluminal Spasmolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Flow Velocity (MFV)
Increase or decrease of Mean Flow Velocity of the medial cerebral artery as determined by Transcranial Doppler.
Measured: Up to 12 hours post intervention
Secondary outcomes (1)
Duration of MFV change after Endoluminal Spasmolysis
Time until Mean Flow Velocity, as determined by Transcranial Doppler, returns to or surpasses baseline.
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Aneurysm HemorrhageStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Peter Rudberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07305922
- Sponsor's protocol ID
- 2025-4055
- Acronym
- Decibel
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Observational, hypothesis-generating study.
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension
- ClinicalTrials.gov ID
- NCT07305922
- Acronym / sponsor ID
- Decibel / 2025-4055
- Keywords
- Transcranial Doppler, Endoluminal Spasmolysis, Induced Hypertension, Multimodal Neuromonitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Dec 2025 (actual)
- 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.
An observational study of patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage, employing multimodal neuromonitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage | – | Drug: Induced hypertension with norepinephrine, Drug: Endoluminal Spasmolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for subarachnoid haemorrhage at the Intensive care unit at Karolinska University Hospital.
Key inclusion criteria (4 listed)
- Adults 18 years or older
- Critical care after subarachnoid haemorrhage
- Aneurysm secured by surgical clipping or endovascular procedure
- Suspected, emerging or established severe cerebral vasospasm
Key exclusion criteria (3 listed)
- Anticipated survival less than five days, as determined by treating clinician
- Transcranial Doppler signal too weak
- Pregnancy
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 |
|---|---|---|
| Induced hypertension with norepinephrineInduced hypertension with norepinephrine and/or dobutamine to attain clinically established goals of cerebral perfusion pressure in a stepwise fashion, according to clinical routine. | Drug | Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage |
| Endoluminal SpasmolysisEndoluminal spasmolysis of cerebral arteries using i.a. Nimodipine, according to clinical protocol and neurointerventionist discretion. | Drug | Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage |
Primary outcome
Mean Flow Velocity (MFV)
Time frame: Up to 12 hours post intervention
Increase or decrease of Mean Flow Velocity of the medial cerebral artery as determined by Transcranial Doppler.
1 secondary outcome
Duration of MFV change after Endoluminal Spasmolysis
Time frame: Up to 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No. Observational, hypothesis-generating study.
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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.
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 Aneurysm Hemorrhage and Cerebral Vasospasm After Subarachnoid Hemorrhage, run by Region Stockholm at 1 site in Sweden.
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 3 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: looking for participants now, as of the sponsor's last update on 26 Dec 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter C Rudberg, M.D. Ph.D. (+46-8-12370000 ext. 72341, peter.rudberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Flow Velocity (MFV) (time frame: Up to 12 hours post intervention). 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 26 Dec 2025.