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Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

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ClinicalTrials.gov Identifier: NCT01347294
Recruitment Status : Recruiting
First Posted : May 4, 2011
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Rune Andersen, Oslo University Hospital

Study Description
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Brief Summary:
The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

Condition or disease Intervention/treatment Phase
Venous Malformation Drug: Bleomycin Drug: Fibrovein Drug: Bleomycin + Fibrovein Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
Study Start Date : August 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


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

Inclusion Criteria:

Venous malformation

Exclusion Criteria:

kidney and lung disease

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347294


Contacts
Contact: Rune Andersen, md +91564775 ruandersen@gmail.com

Locations
Norway
Oslo Universitetssykehus Rikshospitalet Recruiting
Oslo, Norway, 0227
Contact: Rune Andersen, MD    +4723073992    randerse@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Andreas Abildgaard, phd Oslo Universitetssykehus, Rikshospitalet
More Information
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Responsible Party: Rune Andersen, Consultant MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01347294     History of Changes
Other Study ID Numbers: 1331TMF
TMF1331 ( Other Identifier: OsloUH )
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Congenital Abnormalities
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents