Skip to content

Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension

Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07305922
Acronym
Decibel
Enrollment
200
Registered
2025-12-26
Start date
2025-12-01
Completion date
2030-12-31
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Vasospasm After Subarachnoid Hemorrhage, Subarachnoid Aneurysm Hemorrhage

Keywords

Transcranial Doppler, Endoluminal Spasmolysis, Induced Hypertension, Multimodal Neuromonitoring

Brief summary

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

Interventions

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

DRUGEndoluminal Spasmolysis

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

Sponsors

Karolinska Institutet
CollaboratorOTHER
Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean Flow Velocity (MFV)Up to 12 hours post interventionIncrease or decrease of Mean Flow Velocity of the medial cerebral artery as determined by Transcranial Doppler.

Secondary

MeasureTime frameDescription
Duration of MFV change after Endoluminal SpasmolysisUp to 12 hoursTime until Mean Flow Velocity, as determined by Transcranial Doppler, returns to or surpasses baseline.

Other

MeasureTime frameDescription
Associations between Mean Flow Velocity and multimodal neurophysiologic measurement variables after endoluminal spasmolysis or induced hypertension.Up to 12 hoursAssociations 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)).
Associations between Mean Flow Velocity and neuroradiological outcome after induced hypertension or endoluminal spasmolysis.Up to 12 hoursAssociations 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.

Countries

Sweden

Contacts

Primary ContactPeter C Rudberg, M.D. Ph.D.
peter.rudberg@ki.se+46-8-12370000
Backup ContactAnja Rosén, M.D.
anja.rosen@ki.se+46-8-12370000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026