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

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ClinicalTrials.gov Identifier: NCT03212365
Recruitment Status : Completed
First Posted : July 11, 2017
Last Update Posted : October 31, 2019
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Christopher Pannucci, University of Utah

Brief 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized into one of two groups (enoxaparin 40mg twice daily or enoxaparin 0.5mg/kg twice daily, rounded to the nearest milligram).
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery Patients Randomized to Different Postoperative Anticoagulant Regimens
Actual Study Start Date : July 3, 2017
Actual Primary Completion Date : June 2, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Fixed Dose
Participants will receive 40 mg enoxaparin twice daily
Drug: Fixed dose
Participants will receive 40 mg enoxaparin twice daily

Experimental: Variable Dose
Participants will receive 0.5mg/kg enoxaparin twice daily
Drug: Variable dose
Participants will receive 0.5mg/kg enoxaparin twice daily




Primary Outcome Measures :
  1. Anti-Factor Xa levels [ Time Frame: Four hours following third enoxaparin dose ]
    Anti-Factor Xa levels (low, high, or in-range)


Secondary 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 Patients with Bleeding Events [ Time Frame: 90 days ]
    Bleeding events requiring alteration in the course of care within 90 days of surgery



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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:

  • 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

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): NCT03212365


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Stanford University
Investigators
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Principal Investigator: Christopher Puccini, MD University of Utah

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Responsible Party: Christopher Pannucci, Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03212365     History of Changes
Other Study ID Numbers: 100416
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Embolism
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Drug-Related Side Effects and Adverse Reactions
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Chemically-Induced Disorders
Embolism
Lung Diseases
Respiratory Tract Diseases