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

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 2

Conditions: Venous Thromboembolism; Deep Venous Thrombosis; Pulmonary Embolus; Reconstructive Surgery

Treatments: Drug: Fixed dose; Drug: Variable dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03212365

100416

Details and patient eligibility

About

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.

Full 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.

Enrollment: 295 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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295 participants in 2 patient groups

Fixed Dose

Other group

Description:

Participants will receive 40 mg enoxaparin twice daily

Treatment:

Drug: Fixed dose

Variable Dose

Experimental group

Description:

Participants will receive 0.5mg/kg enoxaparin twice daily

Treatment:

Drug: Variable dose