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Early Intervention of Extracranial Arteriovenous Malformations with intralesional bleomycin injections: A Prospective Study

Early Intervention of Extracranial Arteriovenous Malformations with intralesional bleomycin injections: A Prospective Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOB-15007258
Enrollment
Unknown
Registered
2015-10-23
Start date
2014-03-10
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Arteriovenous Malformation

Interventions

bleomycin group:intralesional adminstrated bleomycin

Sponsors

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

Eligibility

Sex/Gender
All
Age
2 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 2-60; 2. With a typical clinical manifestation, coincidental imaging data including CT/MRI, and definitely AVM diagnosis by DSA; 3. The position of the niduses was extracranial, and had not severe vascular communication branches with intracranial vessels according to imaging information; 4. No symptom threatening life such as massive bleeding or heart failure in recent period; 5. No serious underlying systemic disease especially in immune system, respiratory system and circulatory system; 6. Not accepting any therapy in the last 3 months; 7. Ability and willingness to sign an inform consent form after fully understanding the therapeutic strategy and potential risks.

Exclusion criteria

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 bleomycin including pregnancy, lactation or combining with some other drugs like antitumor drug.

Design outcomes

Primary

MeasureTime frame
Digital Subtraction Angiography (DSA);

Countries

China

Contacts

Public ContactXiaoxi Lin
linxiaoxi@126.com+86 13701997136

Outcome results

None listed

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