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Trial record 40 of 56 for:    "Lung Disease" | "Dalteparin"

Enoxaparin Metabolism in Reconstructive Surgery Patients

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ClinicalTrials.gov Identifier: NCT02411292
Recruitment Status : Completed
First Posted : April 8, 2015
Results First Posted : September 13, 2017
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Christopher Pannucci, University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolus Reconstructive Surgery Drug: Enoxaparin Phase 2

Detailed Description:
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. However, the Plastic Surgery Foundation-funded Venous Thromboembolism Prevention Study showed that 1 in 25 highest risk patients still had a "breakthrough" VTE event despite receipt of guideline-compliant enoxaparin prophylaxis. Highest risk patients often have cancer or trauma reconstruction. These surgeries may have surgical injury that is equal in scope to patients with traumatic or thermal injury. Previous work in patients with traumatic or thermal injury has shown that enoxaparin metabolism, measured by anti-factor Xa (aFXa) level, is substantially increased: a higher degree of injury is associated with higher enoxaparin dose requirements to achieve prophylactic levels. "Breakthrough" VTE events may occur in plastic and reconstructive surgery patients due to inadequate enoxaparin dosing. The investigators will examine enoxaparin pharmacokinetics and test whether a clinical protocol for real-time enoxaparin dose adjustment can favorably alter the proportion of patients with in-range aFXa levels. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Enoxaparin Metabolism in Reconstructive Surgery Patients
Actual Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enoxaparin metabolism
Eligible patients will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
Drug: Enoxaparin
Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment of Enoxaparin using a clinical protocol developed with our inpatient pharmacists.




Primary Outcome Measures :
  1. Number 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

  2. Number of Participants With Bleeding Events [ Time Frame: 90 days ]
    Bleeding events requiring alteration in the course of care within 90 days of surgery



Information from the National Library of Medicine

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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:

Inclusion criteria will include:

  • adult (age ≥18) patients presenting for reconstructive surgery under general anesthesia.
  • expected post-operative stay will be at least three days to allow peak aFXa levels to be drawn.
  • eligible patients will include those having major reconstructive surgery.

Exclusion Criteria:

Exclusion criteria will include:

  • 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, or 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): NCT02411292


Locations
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United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Christopher Puccini, MD 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, Plastic Surgery, University of Utah
ClinicalTrials.gov Identifier: NCT02411292     History of Changes
Other Study ID Numbers: IRB 00079118
First Posted: April 8, 2015    Key Record Dates
Results First Posted: September 13, 2017
Last Update Posted: November 16, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Embolism
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Embolism
Respiratory Tract Diseases