Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01347294
Recruitment Status : Recruiting
First Posted : May 4, 2011
Last Update Posted : February 20, 2017
Information provided by (Responsible Party):
Rune Andersen, Oslo University Hospital

April 11, 2011
May 4, 2011
February 20, 2017
August 2011
December 2018   (Final data collection date for primary outcome measure)
Pain [ Time Frame: 1 year ]
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
Complete list of historical versions of study NCT01347294 on Archive Site
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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
Intervention Model: Factorial Assignment
Masking: Triple (Participant, 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.
Same as current
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Venous malformation

Exclusion Criteria:

kidney and lung disease

Sexes Eligible for Study: All
12 Years to 80 Years   (Child, Adult, Senior)
Contact: Rune Andersen, md +91564775
TMF1331 ( Other Identifier: OsloUH )
Not Provided
Plan to Share IPD: No
Rune Andersen, Oslo University Hospital
Oslo University Hospital
Not Provided
Study Director: Andreas Abildgaard, phd Oslo Universitetssykehus, Rikshospitalet
Oslo University Hospital
February 2017

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