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

Launched by THE AFFILIATED HOSPITAL OF GUIZHOU MEDICAL UNIVERSITY · Mar 25, 2024

Keywords

ClinConnect Summary

The FAST-IT Trial is a clinical study aimed at understanding whether injecting a medication called nicardipine directly into the spinal fluid can help patients who have experienced cerebral vasospasm after a type of bleeding in the brain known as aneurysmal subarachnoid hemorrhage. The goal is to see if this treatment improves recovery and outcomes for these patients compared to other methods of administering the medication.

To participate in the trial, patients need to be between 18 and 80 years old and have been diagnosed with spontaneous subarachnoid hemorrhage confirmed by a brain scan. They should also have a brain aneurysm that has been treated and show signs of vasospasm, which can be identified through specific tests or clinical symptoms. Participants will receive the treatment through a small tube placed in their brain or lower back, and they will be closely monitored throughout the study. This trial is currently looking for volunteers, so if you or a loved one might be eligible, it could be a valuable opportunity to help advance treatment for this serious condition.

Gender

ALL

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