Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

University of Oslo (UIO)

Status and phase: Active, not recruiting; Phase 4

Conditions: Venous Malformation

Treatments: Drug: Fibrovein; Drug: Bleomycin; Drug: Bleomycin + Fibrovein

Study type: Interventional

Funder types: Other

Identifiers

NCT01347294

1331TMF

TMF1331 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 12 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of Venous malformation
• Must be able to fill in questionary form
• Must be able to sign informed consent form

Exclusion criteria

• Kidney disease
• Lung disease
• Pregnancy or not willing to safe contraception
• Allergy to Bleomycin or Fibrovein

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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135 participants in 3 patient groups

Bleomycin + Fibrovein

Experimental group

Description:

1) Fibrovein 3% foamed with air 50/ 50. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy. 2) wait 5 minutes 3) Bleomycin 1000 iu / ml. Injected volume same as volume of Fibrovein foam.

Treatment:

Drug: Bleomycin + Fibrovein

Bleomycin

Active Comparator group

Description:

Bleomycin 1000 iu/ ml. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy.

Treatment:

Drug: Bleomycin

Natrium Tetradecyl Sulphate (Fibrovein )

Experimental group

Description:

Fibrovein 3% foamed with air 50/ 50. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy.

Treatment:

Drug: Fibrovein