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

Aneurysmal Subarachnoid Hemorrhage Clinical 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06329635
• Other study ID #: 2023070K
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2024
• Est. completion date: May 2026

Study information

• Verified date: May 2024
• Source: The Affiliated Hospital Of Guizhou Medical University
• Contact: Guangtang Chen, MD
• Phone: +8618286089635
• Email: 18286089635[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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First, 6 ml of cerebrospinal fluid is withdrawn from the EVD or LD catheter, and then 4 ml of nicardipine hydrochloride is injected into the EVD or LD drain tube, followed by 2 ml of 0.9 % sodium chloride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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm

Intervention

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:
• 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.

Locations

Country	Name	City	State
China	Baotou Central Hospital	Baotou	Inner Mongolia Autonomous Region

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital Of Guizhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

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