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Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

Condition Intervention Phase
Venous Malformation
Drug: Bleomycin
Drug: Fibrovein
Drug: Bleomycin + Fibrovein
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 126
Study Start Date: August 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bleomycin + Fibrovein Drug: Bleomycin + Fibrovein
Other Name: Bleomycin Baxter + Fibrovein pharmaceutical products
Active Comparator: Bleomycin Drug: Bleomycin
Other Name: Bleomycin Baxter
Experimental: Natrium Tetradecyl Sulphate (Fibrovein ) Drug: Fibrovein
Other Name: Fibrovein S.T.D pharmaceutical products LTD

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.


Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Venous malformation

Exclusion Criteria:

kidney and lung disease

  Contacts and Locations
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Please refer to this study by its identifier: NCT01347294

Oslo Universitetssykehus Rikshospitalet
Oslo, Norway, 0227
Sponsors and Collaborators
Oslo University Hospital
Study Director: Andreas Abildgaard, phd Oslo Universitetssykehus, Rikshospitalet
  More Information

Responsible Party: Hans Jørgen Smith, Head of Department of Radiology OUS., Department of Radiology, Oslo University Hospital, Norway Identifier: NCT01347294     History of Changes
Other Study ID Numbers: 1331TMF  TMF1331 
Study First Received: April 11, 2011
Last Updated: May 3, 2011

Additional relevant MeSH terms:
Congenital Abnormalities
Antibiotics, Antineoplastic
Antineoplastic Agents processed this record on February 17, 2017