Trial of Treatment of Vasospasm Associated With Aneurysmal Subarachnoid Hemorrhage With Intrathecal Injection of Nicardipine: a Multi-center, Prospective, Double-blinded, Randomized Controlled Trial

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Baotou Central Hospital
RECRUITING
Baotou
Beijing Tiantan Hospital, Affiliated to Capital Medical University
RECRUITING
Beijing
Changzhou First People's Hospital
RECRUITING
Changzhou
West China Airport Hospital of Sichuan University
RECRUITING
Chengdu
Chongqing Ninth People's Hospital
RECRUITING
Chongqing
Ganzhou People's Hospital
RECRUITING
Ganzhou
Southern Medical University Zhujiang Hospital
RECRUITING
Guangzhou
Jinyang Hospital Affiliated to Guizhou Medical University
RECRUITING
Guiyang
The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
The Second Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Hospital
RECRUITING
Hangzhou
Affiliated First Hospital of Anhui Medical University
RECRUITING
Hefei
Jinggangshan University Affiliated Hospital
RECRUITING
Ji’an
Qianfengdong Prefecture People's Hospital
RECRUITING
Kaili
The Second Affiliated Hospital of Guizhou Medical University
RECRUITING
Kaili
Liupanshui City People's Hospital
RECRUITING
Liupanshui
Western Medical University Affiliated Hospital
RECRUITING
Luzhou
Nanning First People's Hospital
RECRUITING
Nanning
Nanyang Central Hospital, Henan Province
RECRUITING
Nanyang
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Affiliated South China Hospital of Shenzhen University
RECRUITING
Shenzhen
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Taian Central Hospital, Shandong Province
RECRUITING
Tai’an
The First Hospital of Shanxi Medical University
RECRUITING
Taiyuan
People's Hospital of Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province
RECRUITING
Xingyi
Qianxinan Prefecture People's Hospital
RECRUITING
Xingyi
Xingyi City People's Hospital
RECRUITING
Xingyi
The First People's Hospital of Zhenjiang City, Jiangsu Province
RECRUITING
Zhenjiang
Contact Information
Primary
Guangtang Chen, MD
18286089635@163.com
+8618286089635
Time Frame
Start Date: 2024-05-27
Estimated Completion Date: 2026-05
Participants
Target number of participants: 396
Treatments
Experimental: Intrathecal Treatment Group
The participants in the IT treatment group will be treated with intrathecal nicardipine injection through EVD or LP draining catheter.
Sham_comparator: Control Group
The participants of the control group will receive no intrathecal nicardipine injection through EVD or LP draining catheter.
Related Therapeutic Areas
Sponsors
Leads: The Affiliated Hospital Of Guizhou Medical University

This content was sourced from clinicaltrials.gov