STAT-STatin and Aspirin in Trauma

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Treatments: Aspirin; Rosuvastatin Calcium

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