Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension

NCT ID: NCT07305922

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2030-12-31

Brief Summary

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

Detailed Description

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Conditions

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Subarachnoid Aneurysm Hemorrhage Cerebral Vasospasm After Subarachnoid Hemorrhage

Keywords

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Transcranial Doppler Endoluminal Spasmolysis Induced Hypertension Multimodal Neuromonitoring

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage

Induced hypertension with norepinephrine

Intervention Type 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.

Endoluminal Spasmolysis

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Endoluminal Spasmolysis

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Region Stockholm

OTHER_GOV

Sponsor Role lead

Responsible Party

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Peter Rudberg

Senior Consultant, Research Group Leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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

Role: CONTACT

Phone: +46-8-12370000

Email: [email protected]

Anja Rosén, M.D.

Role: CONTACT

Phone: +46-8-12370000

Email: [email protected]

Facility Contacts

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Peter C Rudberg, M.D Ph.D.

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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2025-4055

Identifier Type: -

Identifier Source: org_study_id