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Aspirin and Enoxaparin for VTE in Trauma

NCT02396732 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-11-19

Study results available
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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.

Conditions

  • Venous Thromboembolism
  • Thromboprophylaxis
  • Trauma

Interventions

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Kenneth Proctor, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-05-15
Completion
2018-05-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02396732 on ClinicalTrials.gov