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Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients

NCT02412982 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2021-10-25

Study results available
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Summary

This is a pilot study to determine if anti-thrombin III (AT-III) serum concentrations differ between patients with normal versus subtherapeutic anti-Xa trough concentrations when placed on enoxaparin 30 mg twice daily for VTE prophylaxis. Secondarily, this study will compare two enoxaparin dosing strategies.

Conditions

  • Traumatic Injury
  • Venous Thromboembolism

Interventions

DRUG

Enoxaparin 40 mg q12h

Patients receive enoxaparin 40 mg every 12 hours. Dose will be escalated to enoxaparin 50 mg every 12 hours if steady state trough concentration is still subtherapeutic.

DRUG

Enoxaparin 30 mg q8h

Patients receive enoxaparin 30 mg every 8 hours.

Sponsors & Collaborators

  • United States Air Force

    collaborator FED

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Molly Droege, PharmD · UC Health - University of Cincinnati Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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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 NCT02412982 on ClinicalTrials.gov