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

Phase 2

Completed

• Conditions: Venous Thromboembolism; Deep Venous Thrombosis; Pulmonary Embolus; Reconstructive Surgery
• Interventions: Drug: Fixed dose; Drug: Variable dose

• Registration Number: NCT03212365
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-07-03
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-07
• Study First Posted: 2017-07-11
• Primary Completion: 2019-06-02
• Study Completion: 2019-10-01
• Status Verified: 2020-08
• Results First Submitted: 2020-08-06
• Results First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Results First Posted: 2020-09-16
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

Inclusion Criteria

• receiving plastic and reconstructive surgery under general anesthesis
• Expected post-operative stay of 2 days or more

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Dose	Fixed dose	Participants will receive 40 mg enoxaparin twice daily
Variable Dose	Variable dose	Participants will receive 0.5mg/kg enoxaparin twice daily

Primary Outcome Measures

Name	Time	Method
Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL)	Four hours following third enoxaparin dose	Avoidance of over-anticoagulation (peak aFXa \>0.4 IU/mL)
Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL)	Four hours following third enoxaparin dose	Avoidance of under-anticoagulation (peak aFXa \<0.2 IU/mL)

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients With Bleeding Events	90 days	Bleeding events requiring alteration in the course of care within 90 days of surgery
Percentage of Participants With Venous Thromboembolism Events	90 days	Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery

Trial Locations

Locations (2)

Stanford University; 🇺🇸 Stanford, California, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States