|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ChiCTR |
|
Last refreshed on:
|
18 April 2017 |
|
Main ID: |
ChiCTR-IIR-16009220 |
|
Date of registration:
|
2016-09-18 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The protective effect of hydrogen on early brain injury in patient after subarachnoid hemorrhage
|
|
Scientific title:
|
The protective effect of hydrogen on early brain injury in patient after subarachnoid hemorrhage |
|
Date of first enrolment:
|
2016-12-01 |
|
Target sample size:
|
Treatment group:69;control group:69; |
|
Recruitment status: |
Pending |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=15504 |
|
Study type:
|
Interventional study |
|
Study design:
|
Randomized parallel controlled trial
|
|
Phase:
|
New Treatment Measure Clinical Study
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Xin Zhang
|
|
Address:
|
Jinling Hospital, School of Medicine, Nanjing University, 305 East Zhongshan Road, Nanjing, Jiangsu, China
|
|
Telephone:
|
+86 13851879970 |
|
Email:
|
zhangxsp@163.com |
|
Affiliation:
|
Jinling Hospital, School of Medicine, Nanjing University |
|
|
Name:
|
Zong Zhuang
|
|
Address:
|
Jinling Hospital, School of Medicine, Nanjing University, 305 East Zhongshan Road, Nanjing, Jiangsu, China
|
|
Telephone:
|
+86 15850560410 |
|
Email:
|
zhuangzong@126.com |
|
Affiliation:
|
Jinling Hospital, School of Medicine, Nanjing University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Aged 20 to 80 years old, aneurysm rupture, Hunt and Hess grade III or IV, aneurysm treated by interventional embolotherapy within 72 hours after SAH, and written informed consent from the patient or family member.
Exclusion criteria: Severe brain edema, heart dysfunction, renal insufficiency, Fisher grade IV, and rejection of randomization.
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
subarachnoid hemorrhage
|
|
Intervention(s)
|
|
Treatment group:Oral hydrogen-rich water;control group:Oral regular water;
|
|
Primary Outcome(s)
|
|
brain computed tomography;Malondialdehyde;neuron-specific enolase(NSE );S-100 calcium binding protein B;Glasgow Coma Scale;
|
|
Secondary Outcome(s)
|
|
Transcranial color Doppler;C-reactive protein;
|
|
Source(s) of Monetary Support
|
|
National Natural Science Foundation of China (No. 81400980)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|