|
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:
|
30 April 2018 |
|
Main ID: |
ChiCTR1800015220 |
|
Date of registration:
|
2018-03-15 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Prospective evaluation of embolization with absolute alcohol in the treatment of arteriovenous malformations
|
|
Scientific title:
|
Prospective evaluation of embolization with absolute alcohol in the treatment of arteriovenous malformations |
|
Date of first enrolment:
|
2018-03-14 |
|
Target sample size:
|
Ethanol group:30; |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://www.chictr.org.cn/showproj.aspx?proj=25959 |
|
Study type:
|
Observational study |
|
Study design:
|
Before-After control
|
|
Phase:
|
New Treatment Measure Clinical Study
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Xin-dong Fan
|
|
Address:
|
639 Zhizaoju Road, Shanghai, China
|
|
Telephone:
|
+86 021-2965666 |
|
Email:
|
fanxindong@aliyun.com |
|
Affiliation:
|
Shanghai 9th People's Hospital, Shanghai Jiaotong University, School of Medicine |
|
|
Name:
|
Xiao Li
|
|
Address:
|
639 Zhizaoju Road, Shanghai, China
|
|
Telephone:
|
+86 18801906994 |
|
Email:
|
1315771252@qq.com |
|
Affiliation:
|
Shanghai 9th People's Hospital, Shanghai Jiaotong University, School of Medicine |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Aged 2-60 years;
2. With a typical clinical manifestation, coincidental imaging data including CT/MRI diagnosis by DSA;
3. No symptom threatening life such as massive bleeding or heart failure in recent period; No serious underlying systemic disease especially in immune system, respiratory system and circulatory system;
4. Not accepting any therapy in the last 3 months;
5. Ability and willingness to sign an inform consent form after fully understanding the therapeutic strategy and potential risks.
Exclusion criteria: 1. Without a typical clinical manifestation, or having not exactly characters of medical imaging;
2. The nidus was closely connection with intracranial abnormal vessel lesion;
3. Having symptoms threatening life needing to manage immediately;
4. Serious underlying systemic disease requiring treatment until illness either completes therapy or achieves clinical stablility on therapy for at least 6 months before enrolled the study. The systemic diseases include insufficient pulmonary functions(COPD, pneumonia, pulmonary fibrosis and asthma), insufficient cardiac and hepatorenal functions, infection, hemorrhagic tendency, immunologic disease(SLE, urticaria, HIV);
5. Accepting any therapy in the last 3 months including operation or embolization;
6. Refusing to sign an inform consent form after fully understanding the therapeutic strategy and potential risks;
7. Other contraindications of embolization with ethanol including pregnancy, lactation or combining with some other drugs like antitumor drug.
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
arteriovenous malformations
|
|
Intervention(s)
|
|
Ethanol group:Embolization with absolute ethanol;
|
|
Primary Outcome(s)
|
|
Digital Subtraction Angiography (DSA);Clinical manisfestations;
|
|
Source(s) of Monetary Support
|
|
National Natural Science Foundation of China
|
|
Ethics review
|
Status: Approved
Approval date: 25/01/2018
Contact:
Meng Luo
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|