- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347294
Compare Two Different Sclerosing Agents in the Treatment of Venous Malformations
Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Rune Andersen, md
- Phone Number: +91564775
- Email: ruandersen@gmail.com
Study Locations
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Oslo, Norway, 0227
- Oslo Universitetssykehus Rikshospitalet
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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:
|
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:
|
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:
|
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
Sponsor
Investigators
- Study Director: Andreas Abildgaard, Phd, Oslo Universitetssykehus, Rikshospitalet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1331TMF
- TMF1331 (Other Identifier: OsloUH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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