Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension

NCT07305922 | Recruiting

• 1 other identifier: 2025-4055
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

An observational study of patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage, employing multimodal neuromonitoring.

Conditions

Subarachnoid Aneurysm Hemorrhage; Cerebral Vasospasm After Subarachnoid Hemorrhage

Keywords

Transcranial Doppler; Endoluminal Spasmolysis; Induced Hypertension; Multimodal Neuromonitoring

Outcome Measures

Primary Outcomes (1)

• Mean Flow Velocity (MFV)

  Increase or decrease of Mean Flow Velocity of the medial cerebral artery as determined by Transcranial Doppler.

  Up to 12 hours post intervention

Secondary Outcomes (1)

• Duration of MFV change after Endoluminal Spasmolysis

  Up to 12 hours

Other Outcomes (2)

• Associations between Mean Flow Velocity and multimodal neurophysiologic measurement variables after endoluminal spasmolysis or induced hypertension.

  Up to 12 hours

• Associations between Mean Flow Velocity and neuroradiological outcome after induced hypertension or endoluminal spasmolysis.

  Up to 12 hours

Study Arms (1)

Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage

Drug: Induced hypertension with norepinephrine; Drug: Endoluminal Spasmolysis

Interventions

Induced hypertension with norepinephrine DRUG

Induced hypertension with norepinephrine and/or dobutamine to attain clinically established goals of cerebral perfusion pressure in a stepwise fashion, according to clinical routine.

Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage

Endoluminal Spasmolysis DRUG

Endoluminal spasmolysis of cerebral arteries using i.a. Nimodipine, according to clinical protocol and neurointerventionist discretion.

Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Peter C Rudberg, M.D. Ph.D.

CONTACT

+46-8-12370000; peter.rudberg@ki.se

Anja Rosén, M.D.

CONTACT

+46-8-12370000; anja.rosen@ki.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Research Group Leader

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)