BridgeMD
New treatment option for Aneurysmal Subarachnoid Hemorrhage
Official title Treatment of Vasospasm of Aneurysmal Subarachnoid Hemorrhage With Intrathecal Nicardipine - FAST-IT Trial
ClinicalTrials.gov ID: NCT06329635
What this study is testing
What is Intrathecal Nicardipine?
Intrathecal Nicardipine is an investigational medicine, given as a twice-daily injectable medicine, being studied as a potential treatment for aneurysmal subarachnoid hemorrhage.
Also referred to as Treatment group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- 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.
- Any recent brain disease within 3 months, such as tumors, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc.
- History of psychiatric disorders or seizures within 3 months.
See the full eligibility 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).
- Clinical deterioration including mental status change (GCS score decrease \> 2) and focal neurological deficit unable to be attributed to other known neurological reasons.
- Evidence of vasospasm on CTA or DSA, or ischemic change by CTP, MRI.
- Within 14 days of onset of SAH.
- Informed consent obtained from the patient or family member.
- 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.
- Any recent brain disease within 3 months, such as tumors, stroke, epilepsy, vasculitis, arteriovenous malformation, hydrocephalus, etc.
- History of psychiatric disorders or seizures within 3 months.
- Severe concurrent medical conditions.
- Pregnant women or those of childbearing potential with a positive urine or serum β-human chorionic gonadotropin (HCG) test.
- Lactating women.
- Life expectancy of less than 1 year prior to aSAH onset.
- Pre-morbid mRS score \>1.
- Participation in another assigned by chance clinical trial that may confound the evaluation of this study.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Nanning, Guangxi, China
- Guiyang, Guizhou, China
- Kaili, Guizhou, China
- Liupanshui, Guizhou, China
- Xingyi, Guizhou, China
- Kaili, G, China
- Shijiazhuang, Hebei, China
- Nanyang, Henan, China
- Baotou, Inner Mongolia, China
- Changzhou, Jiangsu, China
- Zhenjiang, Jiangsu, China
- Ganzhou, Jiangxi, China
- Ji’an, Jiangxi, China
- Tai’an, Shandong, China
- Shanghai, Shanghai Municipality, China
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Nanning, Guangxi, China and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.