Aspirin and Enoxaparin for VTE in Trauma

The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Trauma; Venous Thromboembolism; Thromboprophylaxis
• Intervention / Treatment: Drug: Aspirin; Drug: Enoxaparin

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Ryder Trauma Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Venous Thromboembolism	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	Up to 2 months of hospitalization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hypercoagulability	Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)	Baseline, up to 2 months hospitalization
Mortality	Mortality will be reported as the number of participants with reported death upon hospital discharge	Up to 2 months of hospitalization

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Kenneth Proctor, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 15, 2018
• Study Completion (Actual): May 15, 2018

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: October 31, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Aspirin; Enoxaparin; Trauma; Thromboprophylaxis; Venous thromboembolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Wounds and Injuries; Thromboembolism; Venous Thromboembolism; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Anticoagulants; Aspirin; Enoxaparin
• Other Study ID Numbers: 20140937

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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