Phase 2
N=295
Minimization of Bleeding Related Adverse Drug Events in Plastic & Reconstructive Surgery
Venous Thromboembolism · Deep Venous Thrombosis · Pulmonary Embolus · Reconstructive Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03212365 ↗Enrolled (actual)
295
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL) — 76.6; 79.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fixed dose (Drug); Variable dose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Avoidance of Under-anticoagulation (Peak aFXa <0.2 IU/mL) |
76.6; 79.9 | — |
| PRIMARY Avoidance of Over-anticoagulation (Peak aFXa >0.4 IU/mL) |
82.2; 90.6 | — |
| SECONDARY Percentage of Participants With Venous Thromboembolism Events |
0.66; 0.69 | — |
| SECONDARY Percentage of Patients With Bleeding Events |
6.0; 8.3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03212365). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.