NCT01347294

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

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.

Conditions

• Venous Malformation

Interventions

Type	Name	Description
DRUG	Bleomycin	Intralesional
DRUG	Fibrovein	Intralesional
DRUG	Bleomycin + Fibrovein	Intralesional

Timeline

• Start date: 2011-08-01
• Primary completion: 2023-11-30
• Completion: 2025-06-30
• First posted: 2011-05-04
• Last updated: 2023-11-07

Locations

1 site across 1 country: Norway