STAT-STatin and Aspirin in Trauma (STAT)
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|ClinicalTrials.gov Identifier: NCT02901067|
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : June 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Wounds and Injuries Venous Thromboembolism||Drug: Aspirin and Rosuvastatin Drug: Placebo (for Aspirin and Rosuvastatin)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||STAT (STatins and Aspirin in Trauma) Trial: 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|
|Actual Study Start Date :||February 3, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Administration of 325mg Aspirin and 20mg of Rosuvastatin mixture in a single capsule daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Drug: Aspirin and Rosuvastatin
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.
Placebo Comparator: Control
Administration of the placebo, which is identical-looking to the Aspirin and Rosuvastatin single capsule mixture, daily either orally or via a feeding tube for the duration of the patient's stay in the ICU.
Drug: Placebo (for Aspirin and Rosuvastatin)
Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
- Incidence of VTE [ Time Frame: Day 5 or ICU discharge or upon symptoms of VTE (whichever comes first) ]Based on screening duplex ultrasound (US) of legs and central line on day 5 or upon ICU discharge or upon symptoms of VTE (whichever comes first).
- Fibrinolysis phenotypes [ Time Frame: During ICU stay at the following timepoints - 6, 12, 24, 48, 72, 120 and 168 hours ]Measured by traditional and tissue plasminogen activator (tPA) - Challenge thrombelastography (TEG) lysis at 30 minutes (LY30).
- Plasminogen activator inhibitor (PAI) - 1 and tissue plasminogen activator (tPA) levels in plasma [ Time Frame: During ICU stay at the following timepoints - 6, 12, 24, 48, 72, 120 and 168 hours ]To be measured in platelet poor plasma (PPP)
- Incidence of acute lung injury (ALI) [ Time Frame: Within two weeks post-injury ]Based on Berlin Criteria
- Ventilator days [ Time Frame: Up to 28 days ]As measured by ventilator-free days
- Incidence of arterial thrombotic complications: myocardial infarction (MI) and cerebrovascular accident (CVA). [ Time Frame: Up to 28 days ]
- All-cause mortality [ Time Frame: 30 days ]
- Intensive care unit (ICU) days [ Time Frame: Up to 28 days ]As measured by ICU-free days
- Incidence of multiple organ failure (MOF) [ Time Frame: Up to 28 days ]As measured by Denver MOF score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02901067
|Contact: Arsen Ghasabyan, MPHemail@example.com|
|Contact: James Chandlerfirstname.lastname@example.org|
|United States, Colorado|
|Denver Health Medical Center||Recruiting|
|Denver, Colorado, United States, 80204|
|Principal Investigator: Ernest E. Moore, M.D.|
|Principal Investigator:||Ernest E Moore, MD||Denver Health Medical Center|