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

Fresenius Kabi Deutschland GmbH0 个研究点目标入组 262 人开始时间: 2016年8月15日最近更新: 2023年9月4日

试验速览

暂无简介。

•Male or female adult patients = 18 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
•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:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 175
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 175

•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 chronic) 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
•Severe hypernatraemia
•Severe hyperchloraemia
•Metabolic alkalosis
•Severely impaired hepatic function
•Severe coagulopathy
•Organ transplant patients
•Simultaneous participation in another clinical interventional trial (drugs or medical devices)

发起方