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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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.


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
Intralesional
Other Name: Bleomycin Baxter + Fibrovein pharmaceutical products
Active Comparator: Bleomycin Drug: Bleomycin
Intralesional
Other Name: Bleomycin Baxter
Experimental: Natrium Tetradecyl Sulphate (Fibrovein ) Drug: Fibrovein
Intralesional
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.

  Eligibility

Ages Eligible for Study:   12 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Venous malformation

Exclusion Criteria:

kidney and lung disease

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

Contacts
Contact: Tone Meyer, md +4740281681 tone.meyer@gmail.com
Contact: Rune Andersen, md +91564775 ruandersen@gmail.com

Locations
Norway
Oslo Universitetssykehus Rikshospitalet Not yet recruiting
Oslo, Norway, 0227
Contact: Hans Jorgen Smith, phd     +4723070000     h.j.smith@medisin.uio.no    
Contact: Andreas Abildgaard, phd     +4723070000     aabildga@ous-hf.no    
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Andreas Abildgaard, phd Oslo Universitetssykehus, Rikshospitalet
  More Information

No publications provided

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

Additional relevant MeSH terms:
Congenital Abnormalities
Bleomycin
Sclerosing Solutions
Antibiotics, Antineoplastic
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013