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

Inclusion Criteria

• •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)