Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT03338218
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03338218
Study Brief:
Protocol Section:
NCT03338218