Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-… (NCT06329635) | Clinical Trial Compass
RecruitingNot Applicable
Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
China396 participantsStarted 2024-05-27
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18-80.
✓. Spontaneous SAH confirmed by head CT.
✓. Saccular brain aneurysm is identified and treated, either surgically or endovascularly.
✓. SAH Fisher grade \>1 or modified Fisher grade \>0.
✓. EVD placed for acute hydrocephalus, or LD placed for draining bloody CSF as deemed necessary by the treating physician.
✓. Any clinical scenario leading to the diagnosis of possible vasospasm, which includes:
✓. Mean flow velocity of MCA \>120, or Lindegaard Ratio ( LR ) \> 3.
✓. 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).
Exclusion criteria
✕. Hunt-Hess Grade 5 or WFNS Grade 5 (no clinical improvement after EVD placement for acute hydrocephalus).
✕. Bacterial or distal aneurysms without subarachnoid hemorrhage in the basal cisterns.
✕. The treating physician determines that the culprit aneurysm has not been fully repaired, with a very high likelihood of rebleeding in the near term.
✕. History of head trauma within the past 3 months.
✕
What they're measuring
1
Dichotomized Modified Rankin Scale (mRS) 0-2 vs 3-6
Timeframe: Day 90±30, Day 365±60.
Trial details
NCT IDNCT06329635
SponsorThe Affiliated Hospital Of Guizhou Medical University