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Clinical Trials/EUCTR2011-001455-37-NO
EUCTR2011-001455-37-NO
Active, not recruiting
Not Applicable

Prospective randomized interventional study. Compare the effect of bleomycin and Tetradecyl Sodium Sulphate (Fibrovein) in the treatment of venous malformations. Clinical neurological and neurophysiological study of a subpopulation of patients with venous malformations.

Department of Radiology, Oslo University Hospital, Norway0 sitesJune 1, 2011
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ConditionsVenous malformationMedDRA version: 13.1Level: LLTClassification code 10047229Term: Venous malformation NOSSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
DrugsBleomycin BaxterFibrovein 3%

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous malformation
Sponsor
Department of Radiology, Oslo University Hospital, Norway
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 1, 2011
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Department of Radiology, Oslo University Hospital, Norway

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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