Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension (Decibel)

December 18, 2025 updated by: Peter Rudberg, Region Stockholm
An observational study of patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage, employing multimodal neuromonitoring.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Peter C Rudberg, M.D. Ph.D.
  • Phone Number: 72341 +46-8-12370000
  • Email: peter.rudberg@ki.se

Study Contact Backup

  • Name: Anja Rosén, M.D.
  • Phone Number: 94856 +46-8-12370000
  • Email: anja.rosen@ki.se

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Recruiting
        • Karolinska University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients treated for subarachnoid haemorrhage at the Intensive care unit at Karolinska University Hospital.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Anticipated survival less than five days, as determined by treating clinician
  • Transcranial Doppler signal too weak
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage
Drug: Induced hypertension with norepinephrine
Induced hypertension with norepinephrine and/or dobutamine to attain clinically established goals of cerebral perfusion pressure in a stepwise fashion, according to clinical routine.
Drug: Endoluminal Spasmolysis
Endoluminal spasmolysis of cerebral arteries using i.a. Nimodipine, according to clinical protocol and neurointerventionist discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 hours post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of MFV change after Endoluminal Spasmolysis
Time Frame: Up to 12 hours
Time until Mean Flow Velocity, as determined by Transcranial Doppler, returns to or surpasses baseline.
Up to 12 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Associations between Mean Flow Velocity and multimodal neurophysiologic measurement variables after endoluminal spasmolysis or induced hypertension.
Time Frame: Up to 12 hours
Associations between Mean Flow Velocities, as determined by Transcranial Doppler, and other neurophysiologic measurement variables, such as pbtO2 (partial pressure brain tissue oxygenation), SbtO2 (brain tissue saturation), qEEG (quantitative EEG), microdialysis parameters, Prx (pressure reactivity index), as well as other physiologic output parameters such as cardiac output, (as determined by left ventricular output or effective pulmonary blood flow (EPBF)).
Up to 12 hours
Associations between Mean Flow Velocity and neuroradiological outcome after induced hypertension or endoluminal spasmolysis.
Time Frame: Up to 12 hours
Associations between Mean Flow Velocity, as determined by Transcranial Doppler, and neuroradiologic outcome parameters such as cerebral artery diameter, perfusion parameters, mean transit time (MTT), ischemic burden.
Up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Stockholm

Collaborators

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Actual)

December 26, 2025

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-4055

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Observational, hypothesis-generating study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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