CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 103 enrolled
Drug / intervention
Enoxaparin 40 mg q12h +1 moredrug
Likely dose
Enoxaparin 40 mg q12hfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02412982
NCT02412982Phase 4Completed
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Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients: A Prospective Randomized Trial of Standard Enoxaparin Versus Two Anti-Xa Adjusted Dosing Strategies

University of Cincinnati·interventional·Posted Apr 9, 2015·Updated Oct 25, 2021

In Brief

A Phase 4 clinical trial evaluating Enoxaparin 40 mg q12h and Enoxaparin 30 mg q8h for Traumatic Injury and Venous Thromboembolism. Completed, enrolled 103 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Injury, Venous Thromboembolism
CountriesUnited States
CollaboratorsUnited States Air Force

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 9, 2015
Enrollment StartMar 1, 2016
Primary CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 11.2 years ago

Interventions

Enoxaparin 40 mg q12hdrug

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.

Enoxaparin 30 mg q8hdrug

Patients receive enoxaparin 30 mg every 8 hours.