Delayed Cerebral Infarction Beyond Endoluminal Spasmolysis and Induced Hypertension

ConditionsSubarachnoid Aneurysm Hemorrhage Cerebral Vasospasm After Subarachnoid Hemorrhage

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorRegion Stockholm

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Anticipated survival less than five days, as determined by treating clinician

Transcranial Doppler signal too weak

Pregnancy

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage2 interventions

Trial outcomes

Primary outcomes

Mean Flow Velocity (MFV)

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

Time frame

Up to 12 hours post intervention

Secondary outcomes

Duration of MFV change after Endoluminal Spasmolysis

Time until Mean Flow Velocity, as determined by Transcranial Doppler, returns to or surpasses baseline.

Time frame

Up to 12 hours

Other outcomes

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

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)).

Time frame

Up to 12 hours

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

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.

Time frame

Up to 12 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Karolinska Institutet

Sponsor institution

Karolinska Institutet

Collaborator

Source ClinicalTrials.gov

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