Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients

Pragmatic, Prospective, Randomized, Controlled, Double-blind, Multi-centre, Multinational Study on the Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients

The aim of the study is to investigate the safety of a 6% hydroxyethyl starch (HES) solution (Volulyte 6%) versus an electrolyte solution (Ionolyte) in trauma patients.

Inclusion:

• Male or female adult patients ≥18 years of age. Women of child bearing 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 estimated blood loss of ≥ 500 ml
• Initial surgery deemed necessary within 24 hrs after trauma
• Deferred signed written informed consent form or as locally required
• No signs of intracranial or cerebral hemorrhage
• Administration of less than 15 ml/kg body weight colloid between trauma injury and hospital admission.

Exclusion:

• 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 24h after traumatic injury
• Sepsis
• Burns
• 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)
• Hyperhydration
• Pulmonary edema
• Dehydration
• Hyperkalemia
• Severe hypernatremia
• Severe hyperchloremia
• Severely impaired hepatic function
• Congestive heart failure
• Severe coagulopathy
• Organ transplant patients
• Metabolic alkalosis
• Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)