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

March 25, 2024 updated by: Zeguang Ren, The Affiliated Hospital Of Guizhou Medical University

Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine: a Multi-center, Prospective, Double-blinded, Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride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

Interventional

Enrollment (Estimated)

396

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intrathecal Treatment Group
The participants in the IT treatment group will be treated with intrathecal nicardipine injection through EVD or LP draining catheter.
Drug: Intrathecal Nicardipine
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.
Other Names:
  • Treatment group
Sham Comparator: Control Group
The participants of the control group will receive no intrathecal nicardipine injection through EVD or LP draining catheter.
Other: No intervention
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.
Other Names:
  • Blank control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6
Time Frame: Day 90±30, Day 365±60.
The percentage of patients with mRS 0-2
Day 90±30, Day 365±60.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extended Glasgow Outcome Score (GOS-E).
Time Frame: Day 90±30, Day 365±60.
Minimum score 1 and maximum score 8 with higher number being better outcome
Day 90±30, Day 365±60.
Modified Rankin Scale ordinal shift with mRS 5 and 6 combined
Time Frame: 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
Day 90±30, Day 365±60.
Dichotomized Modified Rankin Scale (mRS) 0-3 vs 4-6
Time Frame: Day 90±30, Day 365±60.
The percentage of patients with mRS 0-3
Day 90±30, Day 365±60.
Hamilton Depression Rating Scale (HAM-D) score
Time Frame: Day 90±30, Day 365±60.
Minimum score 0 and maximum score 52 with higher score being worse outcome
Day 90±30, Day 365±60.
Hamilton Anxiety Rating Scale (HAM-A) score
Time Frame: Day 90±30, Day 365±60.
Minimum score 0 and maximum score 56 with higher score being worse outcome
Day 90±30, Day 365±60.
Mini-Mental State Examination (MMSE) score
Time Frame: Day 90±30, Day 365±60.
Minimum score 0 and maximum score 30 with higher score being better outcome
Day 90±30, Day 365±60.
Montreal Cognitive Assessment (MoCA) scale score
Time Frame: Day 90±30, Day 365±60.
Minimum score 0 and maximum score 30 with higher score being better outcome
Day 90±30, Day 365±60.
Change of National Institutes of Health Stroke Scale (NIHSS) score
Time Frame: At discharge
NIHSS Scores range from 0 - 42 with higher score being worse outcome
At discharge
Cerebrospinal fluid shunt surgery rate
Time Frame: Day 90±30, Day 365±60.
The incidence of CSF shunt surgery
Day 90±30, Day 365±60.
Overall mortality rate
Time Frame: Day 90±30, Day 365±60.
All etiology of mortality
Day 90±30, Day 365±60.
Rate of CSF infection
Time Frame: Day 30±7
Diagnosed with fever, positive CSF test including culture.
Day 30±7
Rate of any type of new intracranial hemorrhage.
Time Frame: Day 90±30, Day 365±60.
The incidence of CSF shunt surgery
Day 90±30, Day 365±60.
Adverse Event
Time Frame: 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.
Baseline, Day 2-21, Day 30±7, Day 90±30, Day 365±60.
Serious Adverse Event
Time Frame: 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.
Baseline, Day 2-21, Day 30±7, Day 90±30, Day 365±60.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital Of Guizhou Medical University

Investigators

  • Principal Investigator: Zeguang Ren, Affiliated Hospital of Guizhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023070K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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