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

• Status: Recruiting
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: B. Braun Melsungen AG
• Collaborators: European Society of Anaesthesiology; Fresenius Kabi
• Treatments: Hydroxyethyl Starch Derivatives; Pharmaceutical Solutions

Criteria

Inclusion:

• Male or female adult patients ≥18 and ≤ 80 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 haemorrhage

• Base excess < - 4 mEq/l

• 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 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 interventional clinical trial (drugs or medical devices studies)