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Twice Daily Enoxaparin Prophylaxis in Reconstructive Surgery Patients

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ClinicalTrials.gov Identifier: NCT02687204
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Christopher Pannucci, University of Utah

Brief Summary:

Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary embolus) are feared complications of reconstructive surgery. One in ten patients with symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous thrombosis can develop the post-thrombotic syndrome, known to be a major driver of poor quality of life. These phenomena, broadly known as venous thromboembolism (VTE), have substantial downstream ramifications, and the US Surgeon General and the American Society of Plastic Surgeons (ASPS), among others, have underscored the importance of VTE prevention in surgical patients. Reconstructive surgery, most commonly performed to fix traumatic injuries or defects after cancer excision, often involves borrowing tissue from adjacent or distant areas on the body; reconstructive surgery patients can routinely have surgical injury involving 20% or more of their total body surface area. Injury and resultant inflammation are known to increase metabolism of certain drugs, including those used to prevent VTE after surgery.

Enoxaparin is a blood-thinning medication that decreases likelihood of blood clot formation. Previous research has shown that reconstructive surgery patients who are given enoxaparin after surgery are less likely to develop VTE. However, despite receiving of a standard dose of enoxaparin, many patients still develop this life-threatening complication. The investigators believe that patients metabolize enoxaparin differently based on the degree of surgical injury created during reconstruction, and seek to critically examine enoxaparin metabolism in reconstructive surgery patients. The proposed research will evaluate how enoxaparin affects the blood based on standard, ASPS-recommended dosing after reconstructive surgeries; the investigators will also examine whether the extent of surgical injury alters metabolism as well. Enoxaparin effectiveness will be tracked using anti-Factor Xa (aFXa) levels. If subtherapeutic aFXa levels are observed, the study will also design, implement and test a clinical enoxaparin dose-adjustment protocol to achieve appropriate post-operative aFXa levels. Further research based on these data will examine reduction in VTE risk when aFXa-driven enoxaparin dosing is used.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolus Drug: Twice daily enoxaparin prophylaxis Drug: Real time dose adjustment Phase 1

Detailed Description:
The ultimate goal of the investigators research is to better understand the interplay between enoxaparin dosing, degree of surgical injury, and blood clots after major reconstructive surgery. Ultimately, this research will expand medicine's understanding of why post-operative VTE occurs, will allow the investigators to individualize a patient's VTE prophylaxis strategy based on their unique characteristics, and will further improve patient safety after reconstructive surgery.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimization of Enoxaparin Prophylaxis Using Real-time Anti-Factor Xa Levels in Major Reconstructive Surgery Patients
Actual Study Start Date : March 2016
Actual Primary Completion Date : June 23, 2017
Actual Study Completion Date : December 6, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Enoxaparin prophylaxis
All enrolled patients will receive twice daily enoxaparin prophylaxis. Patients with identified out of range peak anti-Xa levels will receive real time dose adjustment and will be considered as the experimental arm.
Drug: Twice daily enoxaparin prophylaxis
Patients will have peak and trough steady state anti-Xa levels drawn. For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed. Repeat steady state levels will be checked.
Other Name: Lovenox

Experimental: Real time dose adjustment
Patients with identified out of range peak anti-Xa levels will receive real time enoxaparin dose adjustment
Drug: Real time dose adjustment
Patients will have peak and trough steady state anti-Xa levels drawn. For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed. Repeat steady state levels will be checked.
Other Name: Lovenox




Primary Outcome Measures :
  1. Number of patients with a 90-day VTE (either a 90-day DVT or 90-day PE) [ Time Frame: 90 days ]
    Outcome measure number one will be deep venous thrombosis or pulmonary embolus confirmed with imaging within 90 days of the initial surgery.


Secondary Outcome Measures :
  1. Number of patients with a 90-day re-operative hematoma [ Time Frame: 90 days ]
    Outcome number two will be bleeding (hematoma) requiring return to the operating room within 90 days of the initial operation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adult patients having plastic and reconstructive surgery who are placed on twice daily enoxaparin prophylaxis after surgery.

Exclusion criteria:

  • Contraindication to use of enoxaparin.
  • Intracranial bleeding/stroke, hematoma or bleeding disorder.
  • Known heparin-induced thrombocytopenia
  • Creatinine clearance ≤30mL/min
  • Serum creatinine >1.6mg/dL
  • Epidural anesthesia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687204


Locations
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United States, Utah
University of Utah Hospitals
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Christopher Pannucci, MD MS University of Utah

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christopher Pannucci, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT02687204     History of Changes
Other Study ID Numbers: 86052
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be shared.
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: 9/4/18
Access Criteria: American Society of Plastic Surgeons

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Embolism
Lung Diseases
Respiratory Tract Diseases
Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action