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临床试验/NCT01347294
NCT01347294进行中(未招募)4 期

Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
135
试验地点
1
主要终点
Intesity, frequency and type of pain.

研究概览

简要总结

The purpose of this study is to determine the effectiveness of bleomycin, fibrovein and bleomycin and fibrovein in the treatment of venous malformation.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Venous malformation
  • Must be able to fill in questionary form
  • Must be able to sign informed consent form

排除标准

  • Kidney disease
  • Lung disease
  • Pregnancy or not willing to safe contraception
  • Allergy to Bleomycin or Fibrovein

研究组 & 干预措施

Bleomycin + Fibrovein

Experimental
  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.

干预措施: Bleomycin + Fibrovein (Drug)

Bleomycin

Active Comparator

Bleomycin 1000 iu/ ml. Total volum injected is the same as volume of malfomation. Volume of malformation estimated by contrast media injection before sclerotherapy.

干预措施: Bleomycin (Drug)

Natrium Tetradecyl Sulphate (Fibrovein )

Experimental

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.

干预措施: Fibrovein (Drug)

结局指标

主要结局

Intesity, frequency and type of pain.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rune Andersen

Principal Investigator

Oslo University Hospital

研究点 (1)

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