Prospective randomized interventional study in patients with venous malformations.

• Conditions: Venous malformation; MedDRA version: 13.1Level: LLTClassification code 10047229Term: Venous malformation NOSSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2011-001455-37-NO
• Lead Sponsor: Department of Radiology, Oslo University Hospital, Norway

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

All patients of both sexes over 12 years referred to hospital with suspected venous malformation will be requested study participation. Written consent must be provided. Patients between 12 and 16 must have parental consent.

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Contraindications to the use of bleomycin:
? Renal impairment
? compromised lung function
? Previously demonstrated hypersensitivity to bleomycin.
? Known previous malignant disease

Contraindications to the use of fibrovein:
? Allergy to sodium tetradecyl sulfate
? Significant obesity
? Heart Failure / Pulmonary Edema
o Previously, severe reaction to X-ray contrast agent
o severe allergies and / or severe bronchial asthma
o Local or systemic infection
o Severe illness that complicates monitoring
o Pregnant / planning pregnancy or breast-feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare the efficacy and side effects of bleomycin and sodium tetradecyl sulfate (Fibrovein ™) in the treatment of venous malformations. Group differences in reported pain after treatment will be the main effect variable. ;Secondary Objective: Secondary outcome measures are relaps rate, physical function, emotional function, subjective assessment of improvement and additional symptoms or side effects. ;Primary end point(s): Primary endpoint is reduction in pain scores one year after treatment with at least 30% difference between the most compared with the least efficacous treatment.<br>VAS (Visual Analogue Scale)shall be used and the standard deviation is estimated to be 2.8 . ;Timepoint(s) of evaluation of this end point: The primary end point is status after one year.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in pain intensity as a function of time and treatment allocation at every time point.;Timepoint(s) of evaluation of this end point: By using various questionnaires that pasients have to fill out, the pain will be measured before starting treatment and then 6 weeks and 12 months after ended treatment.