Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

November 2, 2023 updated by: Rune Andersen, Oslo University Hospital

Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations

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

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Oslo, Norway, 0227
        • Oslo Universitetssykehus Rikshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

Intralesional
Other Names:
  • Bleomycin Baxter + Fibrovein pharmaceutical products
Active Comparator: 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.
Intralesional
Other Names:
  • Bleomycin Baxter
Experimental: 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.
Intralesional
Other Names:
  • Fibrovein S.T.D pharmaceutical products LTD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intesity, frequency and type of pain.
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Andreas Abildgaard, Phd, Oslo Universitetssykehus, Rikshospitalet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2011

Primary Completion (Estimated)

November 30, 2023

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

April 11, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimated)

May 4, 2011

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1331TMF
  • TMF1331 (Other Identifier: OsloUH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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