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Recruiting NCT06329635

Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial

Trial Parameters

Condition Aneurysmal Subarachnoid Hemorrhage
Sponsor The Affiliated Hospital Of Guizhou Medical University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 396
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2024-05-27
Completion 2026-05
Interventions
Intrathecal NicardipineNo intervention

Brief Summary

To investigate whether patients with cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage have a better prognosis with intrathecal nicardipine injection via extraventricular drainage or lumbar drainage.

Eligibility Criteria

Inclusion criteria: 1. Age 18-80. 2. Spontaneous SAH confirmed by head CT. 3. Saccular brain aneurysm is identified and treated, either surgically or endovascularly. 4. SAH Fisher grade \>1 or modified Fisher grade \>0. 5. EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician. 6. Any clinical scenario leading to the diagnosis of possible vasospasm, which includes: 1. Mean flow velocity of MCA \>120, or Lindegaard Ratio ( LR ) \> 3. 2. Any intracranial artery including MCA, ACA, PCA, and BA, TCD showed an upward trend of mean flow velocity for 2 consecutive days (\>25cm/s/day). 3. Clinical deterioration including mental status change (GCS score decrease \> 2) and focal neurological deficit unable to be attributed to other known neurological reasons. 4. Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI. 7. Within 14 days of onset of SAH. 8. Informed consent obtained from the patient or family member. Exclu

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