EUCTR2011-001455-37-NO进行中（未招募）不适用
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 个研究点开始时间: 2011年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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