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

Fresenius Kabi

Status and phase

Completed

Phase 4

Conditions

Hypovolemia Due to Acute Blood Loss

Treatments

Drug: Ionolyte

Drug: Volulyte 6%

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03338218

HE06-021-CP4 (Other Identifier)

HC-G-H-1505

Details and patient eligibility

About

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.

Enrollment

238 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)