Clinical trial NCT06329635: Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
Official title: Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine: a Multi-center, Prospective, Double-blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Vasospasm
Keywords: Aneurysmal Subarachnoid Hemorrhage
Vasospasm
Delayed cerebral ischemia
Nicardipine
Intrathecal injection
Lead sponsor: The Affiliated Hospital Of Guizhou Medical University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride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

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.

Exclusion criteria:

1. Hunt Hess grade 5 or WFNS grade 5 (evaluation after EVD placement for acute hydrocephalus).
2. Need antiplatelet treatment for the embolization of the aneurysm
3. Mycotic or very distal aneurysm with no basal cistern SAH.
4. Culprit aneurysm is deemed as not secured with a very high chance of re-bleeding by the treating physician.
5. Recent head trauma within 3 months.
6. Any recent cerebral disease, such as a brain tumor, stroke, seizure, vasculitis, AVM, or hydrocephalus within 3 months.
7. History of psychological disease, or seizure.
8. Severe other medical morbidities.
9. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test.
10. Female in the breast-feeding.
11. Life expectancy less than 1 year before SAH onset.
12. Before SAH onset mRS \>1.
13. Participation in another randomized clinical trial that could confound the evaluation of the study.
14. Contraindication of using nicardipine

Primary outcomes:
measure: Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6
timeFrame: Day 90±30, Day 365±60.
Secondary outcomes:
measure: Extended Glasgow Outcome Score (GOS-E).
timeFrame: Day 90±30, Day 365±60.
measure: Modified Rankin Scale ordinal shift with mRS 5 and 6 combined
timeFrame: Day 90±30, Day 365±60.
measure: Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6
timeFrame: Day 90±30, Day 365±60.
measure: Hamilton Depression Rating Scale (HAM-D) score
timeFrame: Day 90±30, Day 365±60.
measure: Hamilton Anxiety Rating Scale (HAM-A) score
timeFrame: Day 90±30, Day 365±60.
measure: Mini-Mental State Examination (MMSE) score
timeFrame: Day 90±30, Day 365±60.
measure: Montreal Cognitive Assessment (MoCA) scale score
timeFrame: Day 90±30, Day 365±60.
measure: Change of National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: At discharge
measure: Cerebrospinal fluid shunt surgery rate
timeFrame: Day 90±30, Day 365±60.
measure: Overall mortality rate
timeFrame: Day 90±30, Day 365±60.
measure: Rate of CSF infection
timeFrame: Day 30±7
measure: Rate of any type of new intracranial hemorrhage.
timeFrame: Day 90±30, Day 365±60.
measure: Adverse Event
timeFrame: Baseline, Day 2-21, Day 30±7, Day 90±30, Day 365±60.
measure: Serious Adverse Event
timeFrame: Baseline, Day 2-21, Day 30±7, Day 90±30, Day 365±60.
Other outcomes:
Locations:
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia Autonomous Region
Study officials:
affiliation: Affiliated Hospital of Guizhou Medical University
name: Zeguang Ren
role: PRINCIPAL_INVESTIGATOR
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