Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03339349
The ClinicalTrials.gov registry entry for NCT03339349 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,294-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (99% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Venous Thromboembolism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Venous Thromboembolism Prevention in Outpatients With Glioma
RECRUITING · Phase 2
-
Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
RECRUITING · Phase 2
-
A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
ACTIVE NOT RECRUITING · Phase 2
-
Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism
COMPLETED · Phase 2
-
Detecting the Impact of Statin Therapy On Lowering Risk of Venous Thrombo-Embolic Events (DISOLVE)
COMPLETED · Phase 2
-
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
COMPLETED · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.