Compare the Effect of Bleomycin and Tetradecyl Sodium Sulphate in the Treatment of Venous Malformations
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
- 否
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
-
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.
-
wait 5 minutes
-
Bleomycin 1000 iu / ml. Injected volume same as volume of Fibrovein foam.
干预措施: Bleomycin + Fibrovein (Drug)
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.
干预措施: Bleomycin (Drug)
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.
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
Rune Andersen
Principal Investigator
Oslo University Hospital
