EUCTR2006-002886-38-DE进行中（未招募）不适用
A Multicenter Study on Regenerative Effects of Erythropoitin (LDE) in Burn and Scaled Injuries - EPO in Burns
Faculty of Medicine, Technische Universitaet Muenchen0 个研究点目标入组 150 人开始时间: 2007年12月19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
- 入组人数
- 150
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
- •- 2° and 3° burn and scald thermal injuries, which require operations including split skin harvesting and grafting
- •- Men and women, age > 18 and = 75 years
- •- Secure Contraception
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Admission later than 24 hours after injury
- •- Informed consent missing
- •- Hematological disorders (anaemia, lymphoma, leukemia, inborn coagulation diseases)
- •- Pregnancy or breast-feeding
- •- Estimated survival shorter than one week (abbreviated burn severity index (ABSI) > 12) in patients older than 40 years of age
- •- Total burn surface area involved less than 60 % in patients older than 40 years of age, in patients younger than 40 years of age no limitation of maximum burned body surface and no limitation of ABSI score will be considered
- •- Body weight < 50 kg or > 110 kg
- •- Upper lateral thights of legs thermally injured
- •- Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the protocol.
- •- Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.
- •- Treatment with any investigational product in the last 12 months before study entry
- •- Treatment with any immunosuppressive therapy, cancer-related chemotherapy or radiation therapy in the past 12 months
- •- History of hypersensitivity to the investigational products
- •- Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol (see Section 6.2)
- •- Clinically relevant cardiovascular (s.p. cardiac infarction, coronary heart disease (CHD), thrombembolic disease, thrombembolic events shortly before admission), hepatic (Child B or C liver disease). endocrine (morbid obesity (BMI > 40)) or systemic (cancer) disease (malignoma)
- •- Epileptiform diseases
- •- Phenylketonuria
- •- HIV disease, AIDS
研究者
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