Status:
COMPLETED
Safety and Efficacy of a 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Trauma Patients
Lead Sponsor:
Fresenius Kabi
Collaborating Sponsors:
B. Braun Melsungen AG
European Society of Anaesthesiology and Intensive Care
Conditions:
Hypovolemia Due to Acute Blood Loss
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
February 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2022
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT03338218
Start Date
February 23 2019
End Date
June 25 2022
Last Update
August 5 2022
Active Locations (22)
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1
Ziekenhuis Oost-Limburg-ZOL
Genk, Belgium
2
Fakultni nemocnice Brno
Brno, Czechia
3
Military University Hospital
Prague, Czechia
4
CHRU Nancy - Hôpital Central
Nancy, France