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

Objective:

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.

Design:

This study is a multi-center, prospective, double-blinded, randomized controlled trial.

Interventions:

First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride solution (NaCl), and then the EVD or LD tube was clamped for 2 hours after the injection was completed, then kept open as clinically necessary until the next dose (twice a day).

Inclusion criteria

• Age 18-80.
• Spontaneous SAH confirmed by head CT.
• Saccular brain aneurysm is identified and treated, either surgically or endovascularly.
• SAH Fisher grade >1 or modified Fisher grade >0.
• EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician.
• Any clinical scenario leading to the diagnosis of possible vasospasm, which includes:

• Mean flow velocity of MCA >120, or Lindegaard Ratio ( LR ) > 3.
• 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).
• Clinical deterioration including mental status change (GCS score decrease > 2) and focal neurological deficit unable to be attributed to other known neurological reasons.
• Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.
• Within 14 days of onset of SAH.
• Informed consent obtained from the patient or family member.

Exclusion criteria

• Hunt-Hess Grade 5 or WFNS Grade 5 (no clinical improvement after EVD placement for acute hydrocephalus).
• Bacterial or distal aneurysms without subarachnoid hemorrhage in the basal cisterns.
• The treating physician determines that the culprit aneurysm has not been fully repaired, with a very high likelihood of rebleeding in the near term.
• History of head trauma within the past 3 months.
• Any recent brain disease within 3 months, such as tumors, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc.
• History of psychiatric disorders or seizures within 3 months.
• Severe concurrent medical conditions.
• Pregnant women or those of childbearing potential with a positive urine or serum β-human chorionic gonadotropin (HCG) test.
• Lactating women.
• Life expectancy of less than 1 year prior to aSAH onset.
• Pre-morbid mRS score >1.
• Participation in another randomized clinical trial that may confound the evaluation of this study.