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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-03

Study Completion Date

2019-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Venous Thromboembolism Deep Venous Thrombosis Pulmonary Embolus Reconstructive Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fixed Dose

Participants will receive 40 mg enoxaparin twice daily

Group Type OTHER

Fixed dose

Intervention Type DRUG

Participants will receive 40 mg enoxaparin twice daily

Variable Dose

Participants will receive 0.5mg/kg enoxaparin twice daily

Group Type EXPERIMENTAL

Variable dose

Intervention Type DRUG

Participants will receive 0.5mg/kg enoxaparin twice daily

Interventions

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Fixed dose

Participants will receive 40 mg enoxaparin twice daily

Intervention Type DRUG

Variable dose

Participants will receive 0.5mg/kg enoxaparin twice daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No