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NCT02687204 · ClinicalTrials.gov registry record · Phase 1
Twice Daily Enoxaparin Prophylaxis in Reconstructive Surgery Patients
A Phase 1 study of Venous Thromboembolism and Deep Venous Thrombosis, sponsored by University of Utah.
- Completed
- Registry status
- Phase 1
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT02687204 is a Phase 1 study of Venous Thromboembolism and Deep Venous Thrombosis that has completed, run by University of Utah. The registered enrollment target is 118 participants, below the 6,293-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02687204, a Phase 1 study of Venous Thromboembolism and Deep Venous Thrombosis, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study Summary
Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary embolus) are feared complications of reconstructive surgery. One in ten patients with symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous thrombosis can develop the post-thrombotic syndrome, known to be a major driver of poor quality of life. These phenomena, broadly known as venous thromboembolism (VTE), have substantial downstream ramifications, and the US Surgeon General and the American Society of Plastic Surgeons (ASPS), among others, have underscored the importance of VTE prevention in surgical patients. Reconstructive surgery, most commonly performed to fix traumatic injuries or defects after cancer excision, often involves borrowing tissue from adjacent or distant areas on the body; reconstructive surgery patients can routinely have surgical injury involving 20% or more of their total body surface area. Injury and resultant inflammation are known to increase metabolism of certain drugs, including those used to prevent VTE after surgery. Enoxaparin is a blood-thinning medication that decreases likelihood of blood clot formation. Previous research has shown that reconstructive surgery patients who are given enoxaparin after surgery are less likely to develop VTE. However, despite receiving of a standard dose of enoxaparin, many patients still develop this life-threatening complication. The investigators believe that patients metabolize enoxaparin differently based on the degree of surgical injury created during reconstruction, and seek to critically examine enoxaparin metabolism in reconstructive surgery patients. The proposed research will evaluate how enoxaparin affects the blood based on standard, ASPS-recommended dosing after reconstructive surgeries; the investigators will also examine whether the extent of surgical injury alters metabolism as well. Enoxaparin effectiveness will be tracked using anti-Factor Xa (aFXa) levels. If subtherap
Conditions Studied
Interventions
- DRUG Twice daily enoxaparin prophylaxis
- DRUG Real time dose adjustment
Study Locations (1)
Utah
- University of Utah Hospitals - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-12-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02687204
The ClinicalTrials.gov registry entry for NCT02687204 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,293-participant average among 47 other Venous Thromboembolism trials with a reported enrollment target (98% 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 2 interventions - of which Twice daily enoxaparin prophylaxis is the first listed.
NCT02687204 reports 1 study location spanning 1 distinct geographic area - top geographies include Utah.
Frequently Asked Questions
What is clinical trial NCT02687204 about?
NCT02687204 is a clinical study titled "Twice Daily Enoxaparin Prophylaxis in Reconstructive Surgery Patients". Blood clots that form in the extremities (deep venous thrombosis) and lungs (pulmonary embolus) are feared complications of reconstructive surgery. One in ten patients with symptomatic pulmonary embolus will be dead in 60 minutes. Patients with deep venous thrombosis can develop the post-thrombotic ...
What is the current status of trial NCT02687204?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 118 participants. The study started on 2016-03. Estimated completion is 2017-12-06.
What conditions does trial NCT02687204 study?
This clinical trial studies the following conditions: Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolus.
What interventions are being tested in trial NCT02687204?
The interventions under investigation include: Twice daily enoxaparin prophylaxis (DRUG), Real time dose adjustment (DRUG).
Who is sponsoring clinical trial NCT02687204?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02687204 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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