Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

NCT ID: NCT01347294

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2025-06-30

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.

Conditions

Venous Malformation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Bleomycin + Fibrovein

Intervention Type: DRUG

Intralesional

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.

Group Type: ACTIVE_COMPARATOR

Bleomycin

Intervention Type: DRUG

Intralesional

Natrium Tetradecyl Sulphate (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.

Group Type: EXPERIMENTAL

Fibrovein

Intervention Type: DRUG

Intralesional

Interventions

Bleomycin

Intralesional

Intervention Type: DRUG

Fibrovein

Intralesional

Intervention Type: DRUG

Bleomycin + Fibrovein

Intralesional

Intervention Type: DRUG

Other Intervention Names

Bleomycin Baxter; Fibrovein S.T.D pharmaceutical products LTD; Bleomycin Baxter + Fibrovein pharmaceutical products

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rune Andersen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Abildgaard, Phd

Role: STUDY_DIRECTOR

Oslo Universitetssykehus, Rikshospitalet

Locations

Oslo Universitetssykehus Rikshospitalet

Oslo, , Norway

Countries

Norway

Other Identifiers

TMF1331

Identifier Type: OTHER

Identifier Source: secondary_id

1331TMF

Identifier Type: -

Identifier Source: org_study_id