Pragmatic, controlled, international study conducted in several centres on the safety and therapeutic effect of a Hydroxylethyl-starch (HES) solution versus an electrolyte solution in trauma patients

Phase 1

Conditions: Hypovolaemia due to acute blood loss in trauma surgery
MedDRA version: 19.1Level: PTClassification code 10021137Term: HypovolaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders
Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

Registration Number: EUCTR2016-002176-27-ES

Lead Sponsor: B. Braun Melsungen AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 350

Inclusion Criteria

Male or female adult patients = 18 and = 80 years of age
Women of childbearing potential must test negative on standard pregnancy test (urine or serum)
Patients with blunt or penetrating trauma suffering from an estimated blood loss of = 500 ml
Initial surgery deemed necessary within 24 hours 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 175
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175

Exclusion Criteria

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 24 hours after traumatic injury
Sepsis
Burns
Renal impairment (AKIN stage = 1) or acute and/or chronic renal replacement therapy
Critically ill patients (typically admitted to the intensive care unit)
Dehydration
Hyperhydration
Pulmonary oedema
Congestive heart failure
Hyperkalaemia
Severe hypernatraemia
Severe hyperchloraemia
Metabolic alkalosis
Severely impaired hepatic function
Severe coagulopathy
Organ transplant patients
Simultaneous participation in another clinical interventional trial (drugs or medical devices)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the safety of a 6% HES solution versus an electrolyte solution in trauma patients;Secondary Objective: Further investigation of safety and efficacy of the applied products;Primary end point(s): Composite primary endpoint: 90 day mortality and 90 day renal failure<br><br>Mortality: differentiation between in-hospital and out of hospital will be made<br>Renal failure is defined as biomarker increase as defined by AKIN stage 2 or RIFLE category injury or need for renal replacement therapy (RRT), including haemodialysis, peritoneal dialysis, haemofiltration, and renal transplantation at any time during the first 3 months.;Timepoint(s) of evaluation of this end point: At hospital admission and discharge<br>At ICU admission and discharge<br>90 day mortality and renal failure evaluation at day 90 ± 14 days (Timepoint 4 (T4) = 90 days after randomization)

Secondary Outcome Measures

Name	Time	Method

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