NCT06329635 Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
| NCT ID | NCT06329635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Hospital Of Guizhou Medical University |
| Condition | Aneurysmal Subarachnoid Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2024-05-27 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 396 participants in total. It began in 2024-05-27 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 (no clinical improvement after EVD placement for acute hydrocephalus). 2. Bacterial or distal aneurysms without subarachnoid hemorrhage in the basal cisterns. 3. The treating physician determines that the culprit aneurysm has not been fully repaired, with a very high likelihood of rebleeding in the near term. 4. History of head trauma within the past 3 months. 5. Any recent brain disease within 3 months, such as tumors, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc. 6. History of psychiatric disorders or seizures within 3 months. 7. Severe concurrent medical conditions. 8. Pregnant women or those of childbearing potential with a positive urine or serum β-human chorionic gonadotropin (HCG) test. 9. Lactating women. 10. Life expectancy of less than 1 year prior to aSAH onset. 11. Pre-morbid mRS score \>1. 12. Participation in another randomized clinical trial that may confound the evaluation of this study.
Contact & Investigator
Zeguang Ren
PRINCIPAL INVESTIGATOR
The Affiliated Hospital Of Guizhou Medical University
Frequently Asked Questions
Who can join the NCT06329635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Aneurysmal Subarachnoid Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06329635 currently recruiting?
Yes, NCT06329635 is actively recruiting participants. Contact the research team at 18286089635@163.com for enrollment information.
Where is the NCT06329635 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Chongqing, China, Guangzhou, China and 11 additional locations.
Who is sponsoring the NCT06329635 clinical trial?
NCT06329635 is sponsored by The Affiliated Hospital Of Guizhou Medical University. The principal investigator is Zeguang Ren at The Affiliated Hospital Of Guizhou Medical University. The trial plans to enroll 396 participants.