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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16008047
Enrollment
Unknown
Registered
2016-03-03
Start date
2016-03-01
Completion date
Unknown
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

extracranial arteriovenous malformations

Interventions

bleomycin group:Intralesional Bleomycin Injection

Sponsors

Shanghai 9th People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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).

Design outcomes

Primary

MeasureTime frame
Digital Subtraction Angiography (DSA);

Secondary

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

Countries

China

Contacts

Public ContactXiaoxi Lin

Shanghai 9th People's Hospital, Shanghai Jiaotong University School of Medicine

linxiaoxi@126.com+86 13701997136

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026