Pragmatic, prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of a 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in trauma patients
- Conditions
- 'Hypovolaemia' and 'Decreased blood volume'10014412
- Registration Number
- NL-OMON50632
- Lead Sponsor
- PRA Belgium BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
• Male or female adult patients >= 18 years of age.
• Women of childbearing 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 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
• Hypersensitivity to the active substances or to any of the other excipients
of the IPs, • 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 RRT, • 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 clinical interventional
trial (drugs or medical device studies)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Composite endpoint of 90 day mortality and 90 day renal failure (defined as<br /><br>biomarker increase as defined by AKIN stage 2 or RIFLE injury stage or renal<br /><br>replacement therapy (RRT) during any time during the first 3 months)</p><br>
- Secondary Outcome Measures
Name Time Method