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

Not Applicable

Recruiting

• Conditions: Aneurysmal Subarachnoid Hemorrhage; Vasospasm
• Interventions: Drug: Intrathecal Nicardipine; Other: No intervention

• Registration Number: NCT06329635
• Lead Sponsor: The Affiliated Hospital Of Guizhou Medical University

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First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride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

Study Timeline

• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-25
• Study First Posted: 2024-03-26
• Status Verified: 2024-05
• Study Start: 2024-05-27
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal Treatment Group	Intrathecal Nicardipine	The participants in the IT treatment group will be treated with intrathecal nicardipine injection through EVD or LP draining catheter.
Control Group	No intervention	The participants of the control group will receive no intrathecal nicardipine injection through EVD or LP draining catheter.

Primary Outcome Measures

Name	Time	Method
Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6	Day 90±30, Day 365±60.	The percentage of patients with mRS 0-2

Secondary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale (HAM-A) score	Day 90±30, Day 365±60.	Minimum score 0 and maximum score 56 with higher score being worse outcome
Mini-Mental State Examination (MMSE) score	Day 90±30, Day 365±60.	Minimum score 0 and maximum score 30 with higher score being better outcome
Montreal Cognitive Assessment (MoCA) scale score	Day 90±30, Day 365±60.	Minimum score 0 and maximum score 30 with higher score being better outcome
Extended Glasgow Outcome Score (GOS-E).	Day 90±30, Day 365±60.	Minimum score 1 and maximum score 8 with higher number being better outcome
Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6	Day 90±30, Day 365±60.	The percentage of patients with mRS 0-3
Modified Rankin Scale ordinal shift with mRS 5 and 6 combined	Day 90±30, Day 365±60.	Shift analysis looks at transitions across different levels of mRS score, shifting from higher score to lower score means favorable outcome
Hamilton Depression Rating Scale (HAM-D) score	Day 90±30, Day 365±60.	Minimum score 0 and maximum score 52 with higher score being worse outcome
Rate of any type of new intracranial hemorrhage.	Day 90±30, Day 365±60.	The incidence of CSF shunt surgery
Change of National Institutes of Health Stroke Scale (NIHSS) score	At discharge	NIHSS Scores range from 0 - 42 with higher score being worse outcome
Cerebrospinal fluid shunt surgery rate	Day 90±30, Day 365±60.	The incidence of CSF shunt surgery
Rate of CSF infection	Day 30±7	Diagnosed with fever, positive CSF test including culture.
Overall mortality rate	Day 90±30, Day 365±60.	All etiology of mortality
Adverse Event	Baseline, Day 2-21, Day 30±7, Day 90±30, Day 365±60.	From enrollment to the end of the study, any event meeting the definition of adverse event (AE) was defined as an adverse event, and each occurrence was recorded in a separate adverse event table.
Serious Adverse Event	Baseline, Day 2-21, Day 30±7, Day 90±30, Day 365±60.	During the period from enrollment to the end of the study, any event meeting the definition of serious adverse event (SAE) was defined as serious adverse event, and each occurrence was recorded by a separate adverse event table.

Trial Locations

Locations (1)

Baotou Central Hospital; 🇨🇳 Baotou, Inner Mongolia Autonomous Region, China