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NCT03339349 · ClinicalTrials.gov registry record · Phase 2
Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
A Phase 2 study of Venous Thromboembolism and Deep Vein Thrombosis, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT03339349: Completed Phase 2 study of Venous Thromboembolism and Deep Vein Thrombosis, sponsored by University of Utah.
NCT03339349 is a Phase 2 study of Venous Thromboembolism and Deep Vein Thrombosis that has completed, run by University of Utah. The registered enrollment target is 80 participants, below the 6,294-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03339349, a Phase 2 study of Venous Thromboembolism and Deep Vein Thrombosis, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The rates of Venous thromboembolism (VTE) after orthopedic surgery are as high as 40-60% without prophylactic measures. Enoxaparin, a low-molecular-weight heparin, produces an anticoagulant effect by binding antithrombin, thereby accelerating antithrombin's inactivation of coagulation factor Xa (FXa), thus decreasing the likelihood of clot formation. Despite standard dosing enoxaparin prophylaxis, VTE rates in post-operative orthopedic trauma patients remain as high as 12.2%.The investigators will examine enoxaparin pharmacokinetics and test whether a clinical protocol for real-time enoxaparin dose adjustment can favorably alter the proportion of patients with in-range anti-Factor Xa (aFXa) levels. Outcomes will include peak and trough steady-state aFXa levels in response to standard and escalated doses of enoxaparin and the incidence of venous thromboembolism and bleeding events post-surgery. In the trauma and orthopaedic populations, patients with low initial aFXa levels are significantly more likely to develop deep venous thrombosis. Thus, this study has important implications for appropriate enoxaparin dose magnitude and frequency, and may ultimately help to decrease the substantial morbidity and mortality associated with post-operative VTE.
Primary Outcome
Any symptomatic venous thromboembolism events, including deep venous thrombosis or pulmonary embolus occurring within 90 days of surgery
Conditions Studied
Interventions
- DRUG Enoxaparin
Study Locations (1)
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2017-11-15 |
| Est. Completion | 2019-10-29 |
| Phase | Phase 2 |
What the finished NCT03339349 record still lists
NCT03339349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 6,294-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Venous Thromboembolism appearing as the primary indexed condition, and to 1 intervention - of which Enoxaparin is the first listed.
NCT03339349 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT03339349 about?
NCT03339349 is a clinical study titled "Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma". The rates of Venous thromboembolism (VTE) after orthopedic surgery are as high as 40-60% without prophylactic measures. Enoxaparin, a low-molecular-weight heparin, produces an anticoagulant effect by binding antithrombin, thereby accelerating antithrombin's inactivation of coagulation factor Xa (FXa...
What is the current status of trial NCT03339349?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2017-11-15. Estimated completion is 2019-10-29.
What conditions does trial NCT03339349 study?
This clinical trial studies the following conditions: Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolus.
What interventions are being tested in trial NCT03339349?
The interventions under investigation include: Enoxaparin (DRUG).
Who is sponsoring clinical trial NCT03339349?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03339349 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03339349's enrollment target sits among peer trials
80 38th of 47 higher than 9 of 47 other Venous Thromboembolism trials
participants (enrollment target), bucketed by value
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