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NCT02411292 · ClinicalTrials.gov registry record · Phase 2

Enoxaparin Metabolism in Reconstructive Surgery Patients

A Phase 2 study, sponsored by University of Utah.

Completed
Registry status
Phase 2
Development phase
110
Enrollment target

NCT02411292 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 110 participants.

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The verdict

NCT02411292, a Phase 2 study, has completed, sponsored by University of Utah.

COMPLETED
Registry status
Phase 2
Development phase
110 participants
Enrollment target

Study Summary

Venous thromboembolism (VTE) is a leading cause of death among hospitalized patients, and is an important patient safety issue in plastic surgery. Previous work has shown that enoxaparin prophylaxis can prevent many post-operative VTE events, and current American Society of Plastic Surgeons guidelines support enoxaparin prophylaxis for high-risk patients. Highest risk patients often have cancer or trauma reconstruction. Primary outcomes include 1) peak and trough steady-state aFXa levels in response to standard and escalated doses of enoxaparin and 2) the proportion of patients with appropriate aFXa levels pre and post initiation of a clinical protocol for enoxaparin dose adjustment. The investigators expect that standard dosing will result in inadequate aFXa peak and trough levels, and that the clinical dose adjustment protocol will significantly improve the proportion of in-range aFXa levels. The investigators will also develop a linear regression-based equation to calculate, based on patient-level factors, the required dose of enoxaparin to generate in-range aFXa levels. This research may show that the current "one size fits all" approach to enoxaparin prophylaxis is insufficient. In the trauma and orthopaedic populations, patients with low initial aFXa levels are significantly more likely to develop deep venous thrombosis. Thus, this study has important implications for appropriate enoxaparin dose magnitude and frequency, and may ultimately help to decrease the substantial morbidity and mortality associated with post-operative VTE.

Interventions

  • DRUG Enoxaparin

Trial Details

FieldValue
Enrollment Target 110 participants
Start Date 2015-03
Est. Completion 2016-06
Phase Phase 2

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT02411292

The ClinicalTrials.gov registry entry for NCT02411292 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Enoxaparin is the first listed.

NCT02411292 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02411292 about?

NCT02411292 is a clinical study titled "Enoxaparin Metabolism in Reconstructive Surgery Patients". Venous thromboembolism (VTE) is a leading cause of death among hospitalized patients, and is an important patient safety issue in plastic surgery. Previous work has shown that enoxaparin prophylaxis can prevent many post-operative VTE events, and current American Society of Plastic Surgeons guidelin...

What is the current status of trial NCT02411292?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2015-03. Estimated completion is 2016-06.

What interventions are being tested in trial NCT02411292?

The interventions under investigation include: Enoxaparin (DRUG).

Who is sponsoring clinical trial NCT02411292?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.