ISRCTN95777824已完成未知
A multicentre study on regenerative effects of low-dose erythropoetin in burn and scald injuries
Munich Technical University (Technische Universitaet Munchen) (Germany)0 个研究点目标入组 116 人开始时间: 2007年4月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 116
研究概览
简要总结
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782555 2018 results in https://pubmed.ncbi.nlm.nih.gov/30429786/ (added 18/02/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current criteria as of 22/01/2009:
- •1. 2° and 3° burn and scald thermal injuries, which require operations including split skin harvesting and grafting
- •2. Men and women, aged greater than 18 and less than or equal to 75 years
- •3. Secure contraception
- •Initial information at time of registration:
- •1. Deep 2° and 3° burn and scald thermal injuries, which require operations including split skin harvesting and grafting
- •2. Aged greater than or equal to 18 years
排除标准
- •Current exclusion criteria as of 30/04/2013:
- •1. Admission later than 24 hours after injury
- •2. Haematological disorders (anaemia, lymphoma, leukaemia, inborn coagulation diseases)
- •3. Pregnancy or breast-feeding
- •4. Estimated survival shorter than one week (Abbreviated Burn Severity Index [ABSI] greater than 12) in patient older than 40 years of age
- •5. 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
- •6. Body weight less than 50 kg or greater than 110 kg
- •7. Upper lateral thights of leg thermally injured
- •8. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the protocol
- •9. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
- •10. Treatment with any investigational product in the last 12 months before study entry
- •11. Treatment with any immunosuppressive therapy, cancer-related chemotherapy or radiation therapy in the past 12 months
- •12. History of hypersensitivity to the investigational products
- •13. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- •14. Clinically relevant cardiovascular (s.p. cardiac infarction, coronary heart disease [CHD], thromboembolic disease, thromboembolic events shortly before admission), hepatic (Child B or C liver disease), endocrine (morbid obesity: body mass index [BMI] greater than 40) or systemic (cancer) disease (malignoma)
- •15. Epileptiform diseases
- •16. Phenylketonuria
- •17. Human immunodeficiency virus (HIV) disease, acquired immune-deficiency virus (AIDS)
- •18. Informed consent missing
- •Previous exclusion criteria as of 22/01/2009:
- •Subjects presenting with any of the following will not be included in the study:
- •1. Admission later than 24 hours after injury
- •2. Informed consent given later than 48 hours after trauma
- •3. Suicide attempt
- •4. Skin Graft Donor Site (SGDS) created later than 4 days after trauma
- •5. Begin of treatment with study drug less than 24 hours before creation of SGDS
- •6. Haematological disorders (anaemia, lymphoma, leukaemia, inborn coagulation diseases)
- •7. Pregnancy or breast-feeding
- •8. Estimated survival shorter than one week (Abbreviated Burn Severity Index [ABSI] greater than 12)
- •9. Total burn surface area involved less than 10% or greater than 50%
- •10. Body weight less than 50 kg or greater than 110 kg
- •11. Upper lateral thigh of leg thermally injured
- •12. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
- •13. Subject unlikely to comply with protocol, e.g., uncooperative attitud
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