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Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery

NCT03212365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 295

Last updated 2020-09-16

Study results available
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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.

Conditions

  • Venous Thromboembolism
  • Deep Venous Thrombosis
  • Pulmonary Embolus
  • Reconstructive Surgery

Interventions

DRUG

Fixed dose

Participants will receive 40 mg enoxaparin twice daily

DRUG

Variable dose

Participants will receive 0.5mg/kg enoxaparin twice daily

Sponsors & Collaborators

Principal Investigators

  • Christopher Puccini, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-03
Primary Completion
2019-06-02
Completion
2019-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03212365 on ClinicalTrials.gov