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

The Affiliated Hospital Of Guizhou Medical University396 enrolled

Overview

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.

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 Interventions: First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

396

Conditions

Aneurysmal Subarachnoid Hemorrhage Vasospasm

Interventions

Intrathecal NicardipineDRUG

First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml (4mg) of nicardipine is injected into the EVD or LD drain tube, followed by 2 ml normal saline solution, and then the EVD or LD tube is clamped for 2 hours, and then kept open as clinically necessary until the next dose (q12h) of medication.

No interventionOTHER

A simulated "intrathecal administration" operation is performed by a dedicated physician who is unblinded to the group assignment, the EVD or LD tube is not opened, and no "drug" is given. The simulated administration process needs to be out of the patient's view (if awake patient) and out of the presence of study team personnel.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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. Exclusion criteria: 1. Hunt-Hess Grade 5 or WFNS Grade 5 (no clinical improvement after EVD placement for acute hydrocephalus). 2. Bacterial or distal aneurysms without subarachnoid hemorrhage in the basal cisterns. 3. The treating physician determines that the culprit aneurysm has not been fully repaired, with a very high likelihood of rebleeding in the near term. 4. History of head trauma within the past 3 months. 5. Any recent brain disease within 3 months, such as tumors, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc. 6. History of psychiatric disorders or seizures within 3 months. 7. Severe concurrent medical conditions. 8. Pregnant women or those of childbearing potential with a positive urine or serum β-human chorionic gonadotropin (HCG) test. 9. Lactating women. 10. Life expectancy of less than 1 year prior to aSAH onset. 11. Pre-morbid mRS score \>1. 12. Participation in another randomized clinical trial that may confound the evaluation of this study.

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