Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations
Information source: Oslo University Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
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
|
