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 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT02901067
Eligibility Criteria:
Inclusion Criteria: all adult trauma patients requiring admission to the surgical intensive care unit (SICU) and expected hospital stay for at least 3 days. Outside hospital transfer patients that require SICU admission less than 24 hours after their injury are also eligible for enrollment.
Exclusion criteria for prophylactic anticoagulation and for the study are:
* Known inherited bleeding disorder or coagulopathy
* Known contraindication to pharmacologic anticoagulation
* Spinal column fracture with epidural hematoma
* Head trauma/central nervous system injury
* Severe TBI; defined as AIS Head \>3
* Intracranial hemorrhage; subdural or epidural hematoma
* Neurosurgery service objection; neurosurgical contra-indications will be documented
* Ongoing hemorrhage requiring blood product transfusion
* Thrombocytopenia (platelet count \< 50,000)
* Non-operatively managed liver or spleen injuries Grade III or above
* Known chronic kidney disease (GFR \< 15ml/min)
* Rising creatinine (Cr \> 1.5x baseline) at the time of enrollment
* Inclusion in any other clinical trial
* Documented previous ischemic strokes
In addition, the following exclusion criteria apply:
* Receiving statin or aspirin therapy pre-injury, as potentially being assigned for Control would increase patient's risks
* Known allergy or other contraindication to statins or aspirin
* Pregnant patients
* Prisoners, as their ability to freely consent is impaired
* Inability to obtain consent from patient or proxy prior to 48 hours post-injury
* VTE event (DVT or PE) diagnosed during current hospitalization prior to obtaining informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02901067
Study Brief:
Protocol Section:
NCT02901067