Phase 2 N=131 Other

Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients

Venous Thromboembolism · Deep Venous Thrombosis · Surgery

Bottom Line

View on ClinicalTrials.gov: NCT03251963 ↗

Enrolled (actual)

131

Serious AEs

0.8%

Results posted

Jul 2020

Primary outcome: Primary: Number of Patients With in Range Initial Peak Xa Level — 27; 27 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fixed Dose Enoxaparin (Drug); Variable Dose Enoxaparin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With in Range Initial Peak Xa Level	27; 27	—
SECONDARY Number of Participants With Venous Thromboembolism Events or Death	1; 0	—
SECONDARY Number of Participants With Bleeding Events	1; 3	—

Summary

The aim of this research is to better understand how patient-level factors can be used to predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk reduction and minimize bleeding.

Eligibility Criteria

Inclusion Criteria

receiving Video-Assisted Thoracoscopic Surgery
able to have Enoxaparin initiated within 8 hours after procedure

Exclusion Criteria

Contraindication to use of enoxaparin
Intracranial bleeding/stroke
Hematoma or bleeding disorder
Heparin-induced thrombocytopenia positive
Creatinine clearance less than or equal to 30 mL/min
Serum creatinine greater than 1.6 mg/dL
Epidural catheter

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03251963). 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.