STAT-STatin and Aspirin in Trauma
Condition: Wounds and Injuries; Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism; Wounds and Injuries
Intervention: Aspirin and Rosuvastatin; Placebo (for Aspirin and Rosuvastatin)
Intervention description: Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.; Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
Intervention MeSH terms: Aspirin; Rosuvastatin Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Fibrinolysis

Summary:

      This is a phase II, pragmatic, prospective, randomized, double-blind, adaptive clinical trial
      examining the efficacy of statins and aspirin in the reduction of acute lung injury and
      venous thromboembolism in patients with fibrinolysis shutdown.
    

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