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Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

Primary Purpose

Venous Malformation

Status
Unknown status
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Bleomycin
Fibrovein
Bleomycin + Fibrovein
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Malformation

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Venous malformation

Exclusion Criteria:

kidney and lung disease

Sites / Locations

  • Oslo Universitetssykehus RikshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Bleomycin + Fibrovein

Bleomycin

Natrium Tetradecyl Sulphate (Fibrovein )

Arm Description

Outcomes

Primary Outcome Measures

Pain
Pain will be measured before, during and after treatment. It will be asked about type, characteristics and intensity of pain. Using the VAS 0-10 will be used in this matter.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2011
Last Updated
February 17, 2017
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01347294
Brief Title
Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations
Official Title
Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Malformation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bleomycin + Fibrovein
Arm Type
Experimental
Arm Title
Bleomycin
Arm Type
Active Comparator
Arm Title
Natrium Tetradecyl Sulphate (Fibrovein )
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Other Intervention Name(s)
Bleomycin Baxter
Intervention Description
Intralesional
Intervention Type
Drug
Intervention Name(s)
Fibrovein
Other Intervention Name(s)
Fibrovein S.T.D pharmaceutical products LTD
Intervention Description
Intralesional
Intervention Type
Drug
Intervention Name(s)
Bleomycin + Fibrovein
Other Intervention Name(s)
Bleomycin Baxter + Fibrovein pharmaceutical products
Intervention Description
Intralesional
Primary Outcome Measure Information:
Title
Pain
Description
Pain will be measured before, during and after treatment. It will be asked about type, characteristics and intensity of pain. Using the VAS 0-10 will be used in this matter.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Venous malformation Exclusion Criteria: kidney and lung disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rune Andersen, md
Phone
+91564775
Email
ruandersen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Abildgaard, phd
Organizational Affiliation
Oslo Universitetssykehus, Rikshospitalet
Official's Role
Study Director
Facility Information:
Facility Name
Oslo Universitetssykehus Rikshospitalet
City
Oslo
ZIP/Postal Code
0227
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rune Andersen, MD
Phone
+4723073992
Email
randerse@ous-hf.no

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations

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