NCT01943006已完成3 期
Efficacy and Tolerability of Hirudoid Cream in Prophylaxis and Treatment of Superficial Infusion Thrombophlebitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Medinova AG
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Number of patient developing superficial thrombophlebitis
研究概览
简要总结
Patients receiving nutritional emulsion for at least 3 days will be treated with Hirudoid cream or placebo cream to prevent and treat phlebitis caused by the infusion. The treatment is continued after the end of infusion for at least 7 days.
Number of patients developing superficial phlebitis and duration of phlebitis will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are admitted to the hospital requiring to receive infusion of a complete nutritional emulsion for 3 days (Kabiven® Peripheral, 1400 kcal, 1920 ml, 750 mosmol/L, pH 5.6),
- •Aged 18-65 years.
- •Patients who are able to understand the requirements of the study and agree to sign an informed consent, approved by an Independent Ethic Committee (IEC)/Institutional Review Board (IRB), prior to the study.
排除标准
- •Patients known to be allergic to Hirudoid or any ingredients of Hirudoid
- •Patients with impaired skin integrity caused by lesion or soft tissue trauma
- •Patients having skin lesions with ulcerations or any other severe dermatologic disease
- •Patients has been received a complete nutritional emulsion infusion within 7 days of inclusion
- •Patients with severe uncontrolled medical conditions, which makes it undesirable or unsafe for the patients to participate in the study, such as: Acute or chronic uncontrolled severe infections,Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction, serious uncontrolled cardiac arrhythmia or any other clinically serious cardiac disease, Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN; optimal glycaemic control should be achieved before starting trial therapy, Uncontrolled bleeding
- •Patients known to have coagulation disorders such as Haemophilia, Thrombocytopenia, Thrombosis, Other severe hematologic conditions like leukaemia, especially with abnormal coagulation
- •Patients who have symptoms of microangiopathy (small vessel disease) or neuropathy related to diabetes and other diseases
- •Patients with hyperthyroidism and hypothyroidism
- •Patients who are pregnant or breast feeding
- •Patients who are on anticoagulant therapy (last 2 weeks)
- •Patients with severe psychiatric conditions
- •Patients who are unable to bear legal responsibility or unable to understand the study
- •Patients who are unreliable or unable to comply with the protocol, like alcohol or drug abusers
- •Patients who had been participated in another clinical trial in the past 12 weeks
- •Patient is relatives of, or staff directly reporting to, the investigator
- •Patient is employee of the sponsor
研究组 & 干预措施
Hirudoid cream
Experimental
Patient treated with Hirudoid cream 0.3% Mucopolysaccharide polysulfate
Twice daily
干预措施: Hirudoid cream 0.3 % Mucopolysaccharide polysulfate (Drug)
Placebo
Placebo Comparator
Patients treated with placebo cream without active substance
Twice daily
干预措施: Placebo cream without active substance (Drug)
结局指标
主要结局
Number of patient developing superficial thrombophlebitis
时间窗: 7 days
次要结局
- Investigators' satisfaction(14 days)
- Change of clinical symptoms in patients who developed superficial thrombophlebitis(14 days)
- Time to complete resolution of signs and symptoms in patients who developed superficial thrombophlebitis(14 days)
- Time to develop infusion related superficial thrombophlebitis(7 days)
- Patient' satisfaction(14 days)
- Number of adverse events(14 days)
- Global tolerability(14 days)
研究者
研究点 (4)
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