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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
Sponsor:
Information provided by (Responsible Party):
Ernest E. Moore, MD, Denver Health and Hospital Authority

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Experimental
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. Incidence of acute lung injury (ALI) [ Time Frame: Within two weeks post-injury ]
    Based on Berlin Criteria

  4. Ventilator days [ Time Frame: Up to 28 days ]
    As measured by ventilator-free days

  5. Incidence of arterial thrombotic complications: myocardial infarction (MI) and cerebrovascular accident (CVA). [ Time Frame: Up to 28 days ]
  6. All-cause mortality [ Time Frame: 30 days ]
  7. Intensive care unit (ICU) days [ Time Frame: Up to 28 days ]
    As measured by ICU-free days

  8. Incidence of multiple organ failure (MOF) [ Time Frame: Up to 28 days ]
    As measured by Denver MOF score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Arsen Ghasabyan, MPH 3036023795 arsen.ghasabyan@dhha.org
Contact: James Chandler james.chandler@dhha.org

Locations
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United States, Colorado
Denver Health Medical Center Recruiting
Denver, Colorado, United States, 80204
Principal Investigator: Ernest E. Moore, M.D.         
Sponsors and Collaborators
Denver Health and Hospital Authority
Investigators
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Principal Investigator: Ernest E Moore, MD Denver Health Medical Center
  Study Documents (Full-Text)

Documents provided by Ernest E. Moore, MD, Denver Health and Hospital Authority:
Informed Consent Form  [PDF] February 22, 2019


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Responsible Party: Ernest E. Moore, MD, Professor of Surgery, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT02901067     History of Changes
Other Study ID Numbers: COMIRB 16-0391
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ernest E. Moore, MD, Denver Health and Hospital Authority:
Fibrinolysis
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Wounds and Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Rosuvastatin Calcium
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors