CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 295 enrolled
Drug / intervention
Fixed dose +1 moredrug
Likely dose
Fixed dose 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/NCT03212365
NCT03212365Phase 2Completed

Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery Patients Randomized to Different Postoperative Anticoagulant Regimens

University of Utah·interventional·Posted Jul 11, 2017·Updated Sep 16, 2020

In Brief

A Phase 2 clinical trial evaluating Fixed dose and Variable dose for Venous Thromboembolism and 3 related conditions. Completed, enrolled 295 participants across 2 sites.

Detailed Summary

Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic \& reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic \& reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsStanford University

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 11, 2017
Enrollment StartJul 3, 2017
Primary CompletionJun 2, 2019
Study CompletionOct 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.0 years ago

Interventions

Fixed dosedrug

Participants will receive 40 mg enoxaparin twice daily

Variable dosedrug

Participants will receive 0.5mg/kg enoxaparin twice daily