A Comparative Study of New and Existing Evaluation Methods for Cerebral Circulatory Impairment after Subarachnoid Hemorrhage

JRCT ID: jRCT1040240114

Registered date:29/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Subarachnoid hemorrhage
• Date of first enrollment: 29/10/2024
• Target sample size: 40
• Study type: Interventional

Intervention(s)

Measuring Cutaneous Sympathetic Nerve Activity
In this study, in order to keep the analysis conditions constant, skin sympathetic nerve activity information is obtained while the patient is in a supine position for 30 minutes in a hospital room at rest for 5 minutes before the examination, with 5 electrodes affixed to the chest and connected to a measuring device via an electrocardiogram cable. For cases in which evaluation of cutaneous sympathetic nerve activity is necessary in the extreme phases of severe subarachnoid hemorrhage or vasospasm, continuous 24-hour measurement is performed using continuous data acquisition hardware (Faros180, Faros360 (Bittium)).

Outcome(s)

• Primary Outcome: Delayed cerebral ischemia or stroke up to 14 days after onset of subarachnoid hemorrhage.

Secondary Outcome

Glasgow Coma Scale (GCS) on day 14 after onset of subarachnoid hemorrhage
Modified Rankin Scale (mRS) at the time of discharge
Cerebral vascular flow velocity (measured by TCD)
Degree of intracranial vascular stenosis (as measured by CT, MRI, cerebral angiography)
Laboratory tests of medical course (severity of subarachnoid hemorrhage, fluid balance (estimated by volume of rehydration fluid + fluid intake - urine volume), body weight, TCD, blood collection (electrolytes, IL-10))

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include criteria

Disease name and diagnosis: subarachnoid hemorrhage, diagnosed by imaging (CT, MRI, angiography)
Age: 20 years and older
Gender: any
Severity of subarachnoid hemorrhage: any
Written patient consent: if it is difficult to obtain consent, a person who can obtain consent from a surrogate, such as a family member

Exclude criteria

Relevant major organ function: cases with poor general condition such as severe cardiac disease, takotsubo cardiomyopathy, septic shock, etc.
Cases of subarachnoid hemorrhage with findings of spinal cord consolidation related to autonomic nervous system regulation
Patients who are deemed inappropriate as research subjects by the principal investigator or research coordinator (e.g., subarachnoid hemorrhage due to rupture of dissecting aneurysm, subarachnoid hemorrhage due to rupture of infected aneurysm, and cases diagnosed as having a unique course of subarachnoid hemorrhage, such as traumatic subarachnoid hemorrhage).

Related Information

• Primary Sponsor: Nakada Mitsutoshi