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Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Malformation

Intervention: Bleomycin (Drug); Fibrovein (Drug); Bleomycin + Fibrovein (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Oslo University Hospital

Official(s) and/or principal investigator(s):
Andreas Abildgaard, phd, Study Director, Affiliation: Oslo Universitetssykehus, Rikshospitalet

Overall contact:
Tone Meyer, md, Phone: +4740281681, Email: tone.meyer@gmail.com

Summary

The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

Clinical Details

Official title: Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain

Detailed description: Patients with scanty symptoms from their vascular malformation can do well with conservative treatment and / or with aids and adaptations in daily life. Compression therapy (elastic stockings), pain medication and good counseling is adequate for many. Patients with significant symptoms, however, may require more invasive treatment. Previously, it was common with surgical removal, but serious sequelae and frequent recurrence after surgery resulted in caution. Today it is more common with intervention radiology treatment with injection of sclerosing agents into existing malformation. This type of therapy almost always requires repeated treatment sequences, sometimes over several months. Treatment aims to seal blood vessels in the malformation and / or make the patient as possible symptoms. Recurrence occurs frequently and there are many who are not completely free from symptoms. Many patients have chronic problems with pain, wounds, bleeding and / or they have a cosmetically disfiguring condition. Predicting the performance of a specific type of treatment can be very difficult. Until now, there are some studies that have considered the effect of bleomycin / pingyangmycin (China) and ethanol in the treatment of vascular malformations. To our knowledge there is no prospective or retrospective studies that compare the efficacy and side effects of bleomycin and sodium tetradecyl sulfate (Fibrovein ™) in the treatment of VM.

Eligibility

Minimum age: 12 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: Venous malformation Exclusion Criteria: kidney and lung disease

Locations and Contacts

Tone Meyer, md, Phone: +4740281681, Email: tone.meyer@gmail.com

Oslo Universitetssykehus Rikshospitalet, Oslo 0227, Norway; Not yet recruiting
Hans Jorgen Smith, phd, Phone: +4723070000, Email: h.j.smith@medisin.uio.no
Andreas Abildgaard, phd, Phone: +4723070000, Email: aabildga@ous-hf.no
Additional Information

Starting date: August 2011
Last updated: May 3, 2011

Page last updated: August 20, 2015

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