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

PRA Belgium BV0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年4月15日

适应症

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) (as soon as possible during emergency care), • 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

•Hypersensitivity to the active substances or to any of the other excipients
•of the IPs, • Body weight >= 140 kg, • Patients expected to die within 24 hours
•after traumatic injury, • Sepsis, • Burns, • Renal impairment (AKIN stage >= 1
•or chronic) or acute and/or chronic RRT, • Critically ill patients (typically
•admitted to the intensive care unit), • Hyperhydration, • Pulmonary oedema, •
•Dehydration, • Hyperkalaemia, • Severe hypernatraemia, • Severe
•hyperchloraemia, • Severely impaired hepatic function, • Congestive heart
•failure, • Severe coagulopathy, • Organ transplant patients, • Metabolic
•alkalosis, • Simultaneous participation in another clinical interventional
•trial (drugs or medical device studies)

发起方

PRA Belgium BV