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Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Oslo University Hospital.
Recruitment status was  Not yet recruiting
Information provided by:
Oslo University Hospital Identifier:
First received: April 11, 2011
Last updated: May 3, 2011
Last verified: April 2011

April 11, 2011
May 3, 2011
August 2011
December 2013   (final data collection date for primary outcome measure)
Pain [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Pain will be measured before, during and after treatment. It will be asked about type, characteristics and intensity of pain. Using the VAS 0-10 will be used in this matter.
Same as current
No Changes Posted
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Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations
Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

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.

Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Venous Malformation
  • Drug: Bleomycin
    Other Name: Bleomycin Baxter
  • Drug: Fibrovein
    Other Name: Fibrovein S.T.D pharmaceutical products LTD
  • Drug: Bleomycin + Fibrovein
    Other Name: Bleomycin Baxter + Fibrovein pharmaceutical products
  • Experimental: Bleomycin + Fibrovein
    Intervention: Drug: Bleomycin + Fibrovein
  • Active Comparator: Bleomycin
    Intervention: Drug: Bleomycin
  • Experimental: Natrium Tetradecyl Sulphate (Fibrovein )
    Intervention: Drug: Fibrovein
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not yet recruiting
July 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Venous malformation

Exclusion Criteria:

kidney and lung disease

12 Years to 80 Years   (Child, Adult, Senior)
Contact: Tone Meyer, md +4740281681
Contact: Rune Andersen, md +91564775
1331TMF, TMF1331
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Hans Jørgen Smith, Head of Department of Radiology OUS., Department of Radiology, Oslo University Hospital, Norway
Oslo University Hospital
Not Provided
Study Director: Andreas Abildgaard, phd Oslo Universitetssykehus, Rikshospitalet
Oslo University Hospital
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP