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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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An observational study of patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage, employing multimodal neuromonitoring.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with emerging or established severe cerebral vasospasm after subarachnoid haemorrhage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of MFV change after Endoluminal Spasmolysis | Time until Mean Flow Velocity, as determined by Transcranial Doppler, returns to or surpasses baseline. | Up to 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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)). |
Inclusion Criteria:
Exclusion Criteria:
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Patients treated for subarachnoid haemorrhage at the Intensive care unit at Karolinska University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter C Rudberg, M.D. Ph.D. | Contact | +46-8-12370000 | 72341 | peter.rudberg@ki.se |
| Anja Rosén, M.D. | Contact | +46-8-12370000 | 94856 | anja.rosen@ki.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Recruiting | Stockholm | 17176 | Sweden |
Observational, hypothesis-generating study.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2025 | Dec 18, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Endoluminal Spasmolysis | Drug | Endoluminal spasmolysis of cerebral arteries using i.a. Nimodipine, according to clinical protocol and neurointerventionist discretion. |
|
| 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. | Up to 12 hours |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |