Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations
Recruitment status was Not yet recruiting
The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.
Drug: Bleomycin + Fibrovein
|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|
- 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.
|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)|
|Experimental: Bleomycin + Fibrovein||
Drug: Bleomycin + Fibrovein
Other Name: Bleomycin Baxter + Fibrovein pharmaceutical products
|Active Comparator: Bleomycin||
Other Name: Bleomycin Baxter
|Experimental: Natrium Tetradecyl Sulphate (Fibrovein )||
Other Name: Fibrovein S.T.D pharmaceutical products LTD
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347294
|Contact: Tone Meyer, firstname.lastname@example.org|
|Contact: Rune Andersen, email@example.com|
|Oslo Universitetssykehus Rikshospitalet||Not yet recruiting|
|Oslo, Norway, 0227|
|Contact: Hans Jorgen Smith, phd +4723070000 firstname.lastname@example.org|
|Contact: Andreas Abildgaard, phd +4723070000 email@example.com|
|Study Director:||Andreas Abildgaard, phd||Oslo Universitetssykehus, Rikshospitalet|