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

Last updated: May 28, 2024
Sponsor: The Affiliated Hospital Of Guizhou Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Stroke

Treatment

Intrathecal Nicardipine

No intervention

Clinical Study ID

NCT06329635
2023070K
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Age 18-80.

  2. Spontaneous SAH confirmed by head CT.

  3. Saccular brain aneurysm is identified and treated, either surgically orendovascularly.

  4. SAH Fisher grade >1 or modified Fisher grade >0.

  5. EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemednecessary by the treating physician.

  6. Any clinical scenario leading to the diagnosis of possible vasospasm, whichincludes:

  7. Mean flow velocity of MCA >120, or Lindegaard Ratio ( LR ) > 3.

  8. Any intracranial artery including MCA, ACA, PCA, and BA, TCD showed an upwardtrend of mean flow velocity for 2 consecutive days (>25cm/s/day).

  9. Clinical deterioration including mental status change (GCS score decrease > 2)and focal neurological deficit unable to be attributed to other knownneurological reasons.

  10. Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.

  11. Within 14 days of onset of SAH.

  12. Informed consent obtained from the patient or family member.

Exclusion

Exclusion criteria:

  1. Hunt Hess grade 5 or WFNS grade 5 (evaluation after EVD placement for acutehydrocephalus).

  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 bythe 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 orserum 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 theevaluation of the study.

  14. Contraindication of using nicardipine

Study Design

Total Participants: 396
Treatment Group(s): 2
Primary Treatment: Intrathecal Nicardipine
Phase:
Study Start date:
May 27, 2024
Estimated Completion Date:
May 31, 2026

Study 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).

Connect with a study center

  • Baotou Central Hospital

    Baotou, Inner Mongolia Autonomous Region 014040
    China

    Active - Recruiting

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