Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

Phase 4

Active, not recruiting

• Conditions: Venous Malformation
• Interventions: Drug: Bleomycin + Fibrovein; Drug: Bleomycin; Drug: Fibrovein

• Registration Number: NCT01347294
• Lead Sponsor: Oslo University Hospital

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.

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 Timeline

• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-05-03
• Study First Posted: 2011-05-04
• Study Start: 2011-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-07
• Primary Completion: 2023-11-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Bleomycin + Fibrovein	Bleomycin + Fibrovein	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.
Bleomycin	Bleomycin	Bleomycin 1000 iu/ ml. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy.
Natrium Tetradecyl Sulphate (Fibrovein )	Fibrovein	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.

Primary Outcome Measures

Name	Time	Method
Intesity, frequency and type of pain.	1 year	Pain will be measured before, during and after treatment. It will be asked about type, characteristics and intensity of pain. Using the Visual Analog Score 0-10, 0 beingno pain,10 being maximum pain, will be used in this matter.

Trial Locations

Locations (1)

Oslo Universitetssykehus Rikshospitalet; 🇳🇴 Oslo, Norway