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NCT Number: NCT07305922

Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension

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

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Key information

Conditions

Subarachnoid Aneurysm Hemorrhage Cerebral Vasospasm After Subarachnoid Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location status: Recruiting

Location contact

Peter C Rudberg, M.D Ph.D.

CONTACT

[email protected]

+46-8-12370000 ext. 72341

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Endoluminal Spasmolysis

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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)).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anja Rosén, M.D.

CONTACT

[email protected]

+46-8-12370000 ext. 94856

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

CONTACT

[email protected]

+46-8-12370000 ext. 72341

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Acronym: Decibel

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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