drugset / Trial / NCT03251963
Fixed Versus Weight-Based Enoxaparin Dosing in Thoracic Surgery Patients
Non-randomizedParallel-groupOpen-labelOther
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.
Timeline
- Start
- 2017-09-15
- Primary completion
- 2019-03-27
- Completion
- 2019-07-27
Outcome
Missed primary endpoint
paper Weight-tiered enoxaparin was not significantly more likely to produce adequate anticoagulation (peak anti-factor Xa 0.3 IU/mL or greater) when compared with fixed-dose enoxaparin PMID 32045583 ↗
paper (44.3% vs 48.2%, P = .67). PMID 32045583 ↗
Publications
- Pannucci CJ, Fleming KI, Varghese TK Jr, Stringham J, Huang LC, Pickron TB, Prazak AM, Bertolaccini C, Momeni A. Low Anti-Factor Xa Level Predicts 90-Day Symptomatic Venous Thromboembolism in Surgical Patients Receiving Enoxaparin Prophylaxis: A Pooled Analysis of Eight Clinical Trials. Ann Surg. 2022 Dec 1;276(6):e682-e690. doi: 10.1097/SLA.0000000000004589. Epub 2020 Oct 19.
- Pannucci CJ, Fleming KI, Bertolaccini C, Moulton L, Stringham J, Barnett S, Lin J, Varghese TK Jr. Fixed or Weight-Tiered Enoxaparin After Thoracic Surgery for Venous Thromboembolism Prevention. Ann Thorac Surg. 2020 Jun;109(6):1713-1721. doi: 10.1016/j.athoracsur.2019.12.058. Epub 2020 Feb 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enoxaparin sodium | Other / unclassified | 0.5 mg/kg | — |
| Subject | Enoxaparin sodium | Other / unclassified | 40 mg | — |