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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: 23 March 2020
Main ID:  ChiCTR1900021901
Date of registration: 2019-03-15
Prospective Registration: Yes
Primary sponsor: Xuanwu Hospital, Capital Medical University
Public title: Efficacy and Safety of Thalidomide for the Treatment of Arteriovenous Malformations in Central Nervous System: Pilot Study
Scientific title: Efficacy and Safety of Thalidomide for the Treatment of Arteriovenous Malformations in Central Nervous System: Pilot Study
Date of first enrolment: 2019-03-20
Target sample size: Case series:30;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=36787
Study type:  Observational study
Study design:  Cohort study  
Phase:  0
Countries of recruitment
China
Contacts
Name: Hongqi Zhang   
Address:  45 Changchun Street, Xicheng District, Beijing, China
Telephone: +86 13011858081
Email: xwzhanghq@163.com
Affiliation: 
Name: Jiaxing Yu   
Address:  45 Changchun Street, Xicheng District, Beijing, China
Telephone: +86 15311435081
Email: 15311435081@163.com
Affiliation:  Xuanwu Hospital, Capital Medical University
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients with central nervous system AVMs who can not who can not benefit from current treatment methods.
2. Patients with central nervous system AVM who can refuse to receive current treatment methods.
3. Written informed consent to participate in the study prior to any study procedures.

Exclusion criteria: 1. Pregnant and lactating female patients.
2. Patients younger than 2 years old.
3. Patients who is preparing for pregnancy.
4. Patients with high risks of thrombogenesis (diabetes, severe infection, malignant tumor, history of thrombogenesis, deep vein catheterization and coagulation disorders)
5. Patients with severe comorbidities of cardiac, pulmonary, renal, liver, hematological diseases
6. Patients who is diagnosed as hereditary hemorrhagic telangiectasia (HHT).


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
central nervous system arteriovenous malformations
Intervention(s)
Case series:Oral thalidomide;
Primary Outcome(s)
radiological change;
Secondary Outcome(s)
Pathological test;Neurological outcome;Biomarkers of the blood ;Averse effect;
Secondary ID(s)
Source(s) of Monetary Support
self-financing
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 07/12/2018
Contact:
Zhuoran Zhang
Results
Results available:
Date Posted:
Date Completed:
URL:
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