Hypovolaemia due to acute blood loss in trauma surgery MedDRA version: 20.0 Level: PT Classification code 10021137 Term: Hypovolaemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Volulyte 6% Infusion for solution
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Poly(O-2-hydroxyethyl)starch
CAS Number: 9005-27-0
Other descriptive name: HYDROXYETHYL S
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female adult patients = 18 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 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
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 chronic) 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Mortality: differentiation between in-hospital and out of hospital will be made 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 At ICU admission and discharge 90 day mortality and renal failure evaluation at day 90 ± 14 days (Timepoint 4 (T4) = 90 days after randomization) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety - Renal function: Serum creatinine (SCr), Cystatin-C, SCr based eGFR, Cystatin-C based estimated glomerular filtration rate (eGFR), Cystatin-C based mean eGFR, AKIN stage, highest AKIN on each day (during the first week), RIFLE category, urine output (if available) - Coagulation: Platelet count, International norm ratio (INR), activated partial thromboplastin time (aPTT) - Inflammation: C-reactive protein (C-RP) - Adverse events: (serious) adverse events ((S)AEs / reactions ((S)ARs) - Outcome: Length of stay (LOS) in the hospital (LOS-H), LOS in the intensive care unit (LOS-ICU); fit for discharge from ICU / hospital, need for mechanical ventilation / duration of mechanical ventilation (MV), Mortality (in-hospital / out of hospital) and its cause, need for renal replacement therapy (RRT) / duration of RRT Efficacy - Fluid administration: administration of IP volume - Fluid balance: fluid input and output - Haemodynamics / vital signs: Temperature (T), heart rate (HR), mean arterial pressure (MAP, calculated), systolic arterial blood pressure (SAP), diastolic arterial blood pressure (DAP), central venous pressure (CVP, if available) - and at least one of the following parameters to evaluate responsiveness and guide administration (vol guide): stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI), pulse pressure variation (PPV), mean arterial pressure (measured) Arterial Blood Gas Analysis (ABGA): partial pressure of carbondioxide (pCO2), partial pressure of oxygen (pO2), hydrogen carbonate (HCO3-), arterial oxygen saturation (SaO2), haemoglobin (Hb), haematocrit (Hct), pH, base excess (BE), lactate centralvenous oxygen saturation (ScvO2) Serum electrolytes (S elyte): Sodium, potassium, calcium, chloride Definition of time-points Screening at hospital admission T0 (Baseline, emergency room until IP treatment start) T1 (first 24 hours after IP treatment start) T2 (post-traumatic day 1-3) | — |
Countries
Austria, Belgium, Croatia, Czech Republic, France, Germany, Italy, Netherlands, Romania, Serbia, South Africa, Spain
Contacts
Public ContactMartin Stumpf
Fresenius Kabi Deutschland GmbH
Outcome results
None listed