CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 131 enrolled
Drug / intervention
Fixed Dose Enoxaparin +1 moredrug
Likely dose
Fixed Dose Enoxaparin 40 mgfrom 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/NCT03251963
NCT03251963Phase 2Completed
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Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients

University of Utah·interventional·Posted Aug 16, 2017·Updated Jul 8, 2020

In Brief

A Phase 2 clinical trial evaluating Fixed Dose Enoxaparin and Variable Dose Enoxaparin for Venous Thromboembolism and 2 related conditions. Completed, enrolled 131 participants across 1 site.

Detailed Summary

The aim of this research is to better understand how patient-level factors can be used to predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk reduction and minimize bleeding.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVenous Thromboembolism, Deep Venous Thrombosis, Surgery
CountriesUnited States
CollaboratorsUniversity of Michigan

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 16, 2017
Enrollment StartSep 15, 2017
Primary CompletionMar 27, 2019
Study CompletionJul 27, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.9 years ago

Interventions

Fixed Dose Enoxaparindrug

Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.

Variable Dose Enoxaparindrug

Eligible patients will be administered 0.5 mg/kg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.