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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

Tracking Information
First Submitted Date  ICMJE March 30, 2015
First Posted Date  ICMJE April 8, 2015
Results First Submitted Date  ICMJE June 29, 2017
Results First Posted Date  ICMJE September 13, 2017
Last Update Posted Date November 16, 2018
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2017)
  • 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
  • Number of Participants With Bleeding Events [ Time Frame: 90 days ]
    Bleeding events requiring alteration in the course of care within 90 days of surgery
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
  • anti-Xa low molecular weight heparin (Steady state level (peak) after third dose) [ Time Frame: 4 hours ]
    Steady state level (peak) after third dose
  • anti-Xa low molecular weight heparin (Steady state level (trough) after third dose) [ Time Frame: 12 hours ]
    Steady state level (trough) after third dose
Change History Complete list of historical versions of study NCT02411292 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enoxaparin Metabolism in Reconstructive Surgery Patients
Official Title  ICMJE Enoxaparin Metabolism in Reconstructive Surgery Patients
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Venous Thromboembolism
  • Deep Venous Thrombosis
  • Pulmonary Embolus
  • Reconstructive Surgery
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Drug: Enoxaparin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2017)
110
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2015)
200
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02411292
Other Study ID Numbers  ICMJE IRB 00079118
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christopher Pannucci, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Puccini, MD University of Utah
PRS Account University of Utah
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP