Early intervention of extracranial arteriovenous malformations with bleomycin: a prospective, multicenter, single-blind, randomized, controlled clinical trial

• Register: ChiCTR
• Last refreshed on: 8 January 2018
• Main ID: ChiCTR-IOR-16008047
• Date of registration: 2016-03-03
• Prospective Registration: No
• Primary sponsor: Shanghai 9th People's Hospital, Shanghai Jiaotong University School of Medicine
• Public title: Early intervention of extracranial arteriovenous malformations with bleomycin: a prospective, multicenter, single-blind, randomized, controlled clinical trial
• Scientific title: Early intervention of extracranial arteriovenous malformations with bleomycin: a prospective, multicenter, single-blind, randomized, controlled clinical trial
• Date of first enrolment: 2016-03-01
• Target sample size: bleomycin group:80;Control group:40;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=13531
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Xiaoxi Lin
• Affiliation: Shanghai 9th People's Hospital, Shanghai Jiaotong University School of Medicine

• Name: Xiaoxi Lin
• Affiliation: Shanghai 9th People's Hospital, Shanghai Jiaotong University School of Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1. In line with the diagnostic criteria of ISSVA for early arteriovenous malformations (Schobinger stage Phase I/II) containing superficial lesions;
2. Having not accepted any therapy;
3. No drug contraindications of bleomycin, including allergy, pregnant or lactating;
4. Ability and willingness to sign an inform consent form after fully understanding the therapeutic and follow-up strategies.
Exclusion criteria: 1. Aged above 70.
2. Insufficient pulmonary functions and hepatorenal functions.
3. Patients with fever or WBC less than 2500 / cubic millimeter.
4. The combined use of other anti-tumor drugs.
5. 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).

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

extracranial arteriovenous malformations

Intervention(s)

bleomycin group:Intralesional Bleomycin Injection;Control group:No medicine;

Primary Outcome(s)

Digital Subtraction Angiography (DSA);

Secondary Outcome(s)

Regression degree of DSA;Visual analogue scale(VAS);Micro-ultrasound imaging;Lesions temperature;Lesions color;

Source(s) of Monetary Support

None

Ethics review

Status: Approved
Approval date: 26/07/2017
Contact:

Luo Meng

[phone]-5576