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Aspirin and Enoxaparin for VTE in Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02396732
Recruitment Status : Terminated (Terminated due to futility and less subjects meeting entry criteria)
First Posted : March 24, 2015
Results First Posted : November 19, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Kenneth Proctor, University of Miami

Brief Summary:
The purpose of this study is to determine if the addition of antiplatelet therapy (i.e. aspirin) to low-molecular-weight-heparin (i.e. enoxaparin) will decrease the incidence of venous thromboembolism (VTE) in high-risk critically injured patients. The investigators further aim to determine the safety and efficacy of dual thromboprophylaxis with aspirin and enoxaparin for decreasing the incidence of VTE after trauma.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Thromboprophylaxis Trauma Drug: Aspirin Drug: Enoxaparin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial
Study Start Date : February 2016
Actual Primary Completion Date : May 15, 2018
Actual Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)
Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
Drug: Aspirin
Daily dose is 81 mg oral tablet

Drug: Enoxaparin
Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.

Active Comparator: Low Molecular Weight Heparin (LMWH) Alone
Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
Drug: Enoxaparin
Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.




Primary Outcome Measures :
  1. Incidence of Venous Thromboembolism [ Time Frame: Up to 2 months of hospitalization ]
    Incidence of VTE is defined as new cases reported of: 1. Deep Vein Thrombosis (DVT), symptomatic or asymptomatic as assessed via venous duplex ultrasonography, and 2. Pulmonary Embolism (PE), symptomatic or asymptomatic as assessed via chest computed tomography with angiography (CTA) or ventilation-perfusion (VQ) Scan


Secondary Outcome Measures :
  1. Change in Hypercoagulability [ Time Frame: Baseline, up to 2 months hospitalization ]
    Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)

  2. Mortality [ Time Frame: Up to 2 months of hospitalization ]
    Mortality will be reported as the number of participants with reported death upon hospital discharge



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Blunt or penetrating trauma
  • Requires VTE thromboprophylaxis
  • High-risk for VTE

Exclusion Criteria:

  • Presence of VTE upon admission
  • Pregnant or nursing
  • Inability to give informed consent by patient or healthcare proxy
  • Contraindication to enoxaparin
  • Contraindication to aspirin
  • Epidural or subdural hematoma
  • Presence, or removal within the last 12 hours, of an epidural or spinal catheter, or recent (within the last 12 hours) epidural or spinal anesthesia/procedures

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): NCT02396732


Locations
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United States, Florida
Ryder Trauma Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Kenneth Proctor, PhD University of Miami
  Study Documents (Full-Text)

Documents provided by Kenneth Proctor, University of Miami:

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Responsible Party: Kenneth Proctor, Professor of Surgery, University of Miami
ClinicalTrials.gov Identifier: NCT02396732    
Other Study ID Numbers: 20140937
First Posted: March 24, 2015    Key Record Dates
Results First Posted: November 19, 2019
Last Update Posted: November 19, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Kenneth Proctor, University of Miami:
Aspirin
Enoxaparin
Thromboprophylaxis
Trauma
Venous thromboembolism
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Wounds and Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Heparin, Low-Molecular-Weight
Dalteparin
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
Anticoagulants