Clinical trial NCT03212365: Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Official title: Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery Patients Randomized to Different Postoperative Anticoagulant Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Venous Thromboembolism
Deep Venous Thrombosis
Pulmonary Embolus
Reconstructive Surgery
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2017-07-11
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL)
timeFrame: Four hours following third enoxaparin dose
measure: Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL)
timeFrame: Four hours following third enoxaparin dose
Secondary outcomes:
measure: Percentage of Participants With Venous Thromboembolism Events
timeFrame: 90 days
measure: Percentage of Patients With Bleeding Events
timeFrame: 90 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Christopher Puccini, MD
role: PRINCIPAL_INVESTIGATOR
References: