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Aspirin and Enoxaparin for VTE in Trauma

Primary Purpose

Venous Thromboembolism, Thromboprophylaxis, Trauma

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Enoxaparin
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Aspirin, Enoxaparin, Thromboprophylaxis, Trauma, Venous thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ryder Trauma Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)

Low Molecular Weight Heparin (LMWH) Alone

Arm Description

Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.

Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Hypercoagulability
Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)
Mortality
Mortality will be reported as the number of participants with reported death upon hospital discharge

Full Information

First Posted
March 12, 2015
Last Updated
October 31, 2019
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02396732
Brief Title
Aspirin and Enoxaparin for VTE in Trauma
Official Title
The Role Of Combined Therapy With Aspirin and Enoxaparin In Prevention Of Venous Thromboembolism In Trauma Patients: A Randomized-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to futility and less subjects meeting entry criteria
Study Start Date
February 2016 (undefined)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Thromboprophylaxis, Trauma
Keywords
Aspirin, Enoxaparin, Thromboprophylaxis, Trauma, Venous thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Molecular Weight Heparin (LMWH) + Aspirin (ASA)
Arm Type
Experimental
Arm Description
Group will get both enoxaparin (standard of care) and aspirin (intervention) after consent up to Intensive Care Unit (ICU) discharge.
Arm Title
Low Molecular Weight Heparin (LMWH) Alone
Arm Type
Active Comparator
Arm Description
Group will get only enoxaparin (standard of care) after consent up to Intensive Care Unit (ICU) discharge.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
Daily dose is 81 mg oral tablet
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.
Primary Outcome Measure Information:
Title
Incidence of Venous Thromboembolism
Description
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
Time Frame
Up to 2 months of hospitalization
Secondary Outcome Measure Information:
Title
Change in Hypercoagulability
Description
Assessed via the combination of routine laboratory values (Prothrombin Time and Partial Thromboplastin Time) evaluated through weekly thromboelastography (TEG)
Time Frame
Baseline, up to 2 months hospitalization
Title
Mortality
Description
Mortality will be reported as the number of participants with reported death upon hospital discharge
Time Frame
Up to 2 months of hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Proctor, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ryder Trauma Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Aspirin and Enoxaparin for VTE in Trauma

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