Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

This study is not yet open for participant recruitment.
Verified April 2011 by Oslo University Hospital
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01347294
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
Complete list of historical versions of study NCT01347294 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
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
    Intralesional
    Other Name: Bleomycin Baxter
  • Drug: Fibrovein
    Intralesional
    Other Name: Fibrovein S.T.D pharmaceutical products LTD
  • Drug: Bleomycin + Fibrovein
    Intralesional
    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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
126
July 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Venous malformation

Exclusion Criteria:

kidney and lung disease

Both
12 Years to 80 Years
No
Contact: Tone Meyer, md +4740281681 tone.meyer@gmail.com
Contact: Rune Andersen, md +91564775 ruandersen@gmail.com
Norway
 
NCT01347294
1331TMF, TMF1331
No
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