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

August 31, 2020 updated by: Christopher Pannucci, University of Utah

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

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 Overview

Detailed Description

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). Our preliminary data has shown that a fixed, or "one size fits all" dose of enoxaparin, an anticoagulant, can allow a high proportion of patients to have appropriately thinned blood, measured by anti-Factor Xa (aFXa) levels. Patients with adequate aFXa levels are known to have significantly decreased venous thromboembolism risk (VTE), which is desirable. However, 30% of patients who receive fixed dose enoxaparin have blood that is too thin. Patients who are over-anticoagulated are significantly more likely to have ADEs including bleeding requiring return to the operating room, need for blood transfusion, or death. The optimal way to dose enoxaparin to minimize ADEs remains unknown. 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 Type

Interventional

Enrollment (Actual)

295

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Stanford University
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • receiving plastic and reconstructive surgery under general anesthesis
  • Expected post-operative stay of 2 days or more

Exclusion Criteria:

  • Contraindication to use of enoxaparin
  • intracranial bleeding/stroke
  • Hematoma or bleeding disorder
  • Heparin-induced thrmbocytopenia positive
  • Creatinine clearance less than or equal to 30 mL/min
  • Serum creatinine greater than 1.6 mg/dL
  • epidural anesthesia
  • patients placed on non-enoxaparin chemoprophylaxis regimens
  • gross weight exceeding 150kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fixed Dose
Participants will receive 40 mg enoxaparin twice daily
Participants will receive 40 mg enoxaparin twice daily
Experimental: Variable Dose
Participants will receive 0.5mg/kg enoxaparin twice daily
Participants will receive 0.5mg/kg enoxaparin twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL)
Time Frame: Four hours following third enoxaparin dose
Avoidance of under-anticoagulation (peak aFXa <0.2 IU/mL)
Four hours following third enoxaparin dose
Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL)
Time Frame: Four hours following third enoxaparin dose
Avoidance of over-anticoagulation (peak aFXa >0.4 IU/mL)
Four hours following third enoxaparin dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Venous Thromboembolism Events
Time Frame: 90 days
Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
90 days
Percentage of Patients With Bleeding Events
Time Frame: 90 days
Bleeding events requiring alteration in the course of care within 90 days of surgery
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Christopher Puccini, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2017

Primary Completion (Actual)

June 2, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 7, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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