EUCTR2016-002176-27-ES
进行中（未招募）
1 期
Pragmatic, prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of a 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in trauma patients - TETHYS
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- B. Braun Melsungen AG
- 入组人数
- 350
- 状态
- 进行中（未招募）
- 最后更新
- 7年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Male or female adult patients \= 18 and \= 80 years of age
- •Women of childbearing potential must test negative on standard pregnancy test (urine or serum)
- •Patients with blunt or penetrating trauma suffering from an estimated blood loss of \= 500 ml
- •Initial surgery deemed necessary within 24 hours after trauma
- •Deferred signed written informed consent form or as locally required
- •No signs of intracranial or cerebral haemorrhage
- •Base excess \< \- 4 mEq/l
- •Administration of less than 15 ml/kg body weight colloid between trauma injury and hospital admission
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
排除标准
- •Hypersensitivity to the active substances or to any of the other excipients of the investigational products
- •Body weight \= 140 kg
- •Patients expected to die within 24 hours after traumatic injury
- •Renal impairment (AKIN stage \= 1\) or acute and/or chronic renal replacement therapy
- •Critically ill patients (typically admitted to the intensive care unit)
- •Dehydration
- •Hyperhydration
- •Pulmonary oedema
- •Congestive heart failure
- •Hyperkalaemia
结局指标
主要结局
未指定
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