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 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT02972593
Eligibility Criteria:
Inclusion Criteria:
* Trauma patients admitted to participating hospital with any Orthopaedic injury who have been determined to be stable by the Trauma Service (General Surgery) and are no longer within the resuscitation phase of initial treatment. This is defined as a normal urine output (greater than 0.5 ml/kg/hr) and a systolic blood pressure greater than 90 mmHg for greater than 6 hours without fluid bolus or transfusion during that time
* Age 18-50
* Hemoglobin less than 9 g/dL or expected drop below 9 g/dL with planned surgery
Exclusion Criteria:
* Pregnant ( urine pregnancy test will be done as standard of care)
* Prisoner
* Head injury (Glasgow Coma Scale less than 8 over 48 hours from presentation)
* Known cardiac (coronary artery disease, atrial fibrillation, stent placement, congestive heart failure), renal (acute or chronic renal insufficiency or failure, defined as having Serum Creatinine \>1.2 at time of enrollment), liver (Childs C cirrhosis) or pulmonary disease (chronic obstructive pulmonary disease, abnormal pulmonary function tests or history of poor pulmonary function from any cause including acute traumatic conditions such as ARDS)
* Unlikely to follow up in the surgeon's estimation
* Sickle Cell Anemia
* History of cancer
* Preexisting weakness, paresthesias, deformities, or other conditions which might affect functional outcome in the surgeon's opinion
* Spinal cord injury
* Patients with burns expected to require operative treatment
* COVID positive
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02972593
Study Brief:
Protocol Section:
NCT02972593