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NCT03031457 · ClinicalTrials.gov registry record
Microsurgical Breast Reconstruction & VTE
A clinical trial, sponsored by Stanford University.
- Completed
- Registry status
- 30
- Enrollment target
NCT03031457: Completed study, sponsored by Stanford University.
NCT03031457 is a clinical trial that has completed, run by Stanford University. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03031457 has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery. Significant morbidity and mortality is associated with VTE events. This disease entity represents the most common cause of preventable in-hospital death as evidenced by over 100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial, with annual costs to the U.S. healthcare system in excess of $7 billion. Cancer patients have been identified as a particularly vulnerable patient population. Of these, breast cancer patients represent the largest group treated by plastic surgeons. An increasing number of breast reconstructions are performed in the U.S. with a documented 35% increase in the annual number of breast reconstructions since 2000. Over 106,000 breast reconstructions were performed in 2015 alone. Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is associated with the highest risk for VTE. We believe that a key element rendering these patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is supported by the observation that VTE risk remains elevated for up to 12 weeks postoperatively. We hypothesize that lower extremity deep venous system stasis is a procedure-specific key contributing factor to postoperative VTE risk. This study examines the duration of postoperative lower extremity venous stasis to identify patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging technology to examine the lower extremity deep venous system preoperatively, on postoperative day 1, and on the day of discharge to determine if patients display radiographic evidence of lower extremity venous stasis at the time of hospital discharge. A better understanding of pathophysiologic mechanisms that contribute to the development of VTE as well as surgical means that re
Interventions
- DIAGNOSTIC_TEST Duplex ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-01-30 |
| Est. Completion | 2017-12-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03031457
The ClinicalTrials.gov registry entry for NCT03031457 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Duplex ultrasound is the first listed.
NCT03031457 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03031457 about?
NCT03031457 is a clinical study titled "Microsurgical Breast Reconstruction & VTE". Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery. Significant morbidity and mortality is associated with VTE events. This disease entity represents the most common c...
What is the current status of trial NCT03031457?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2017-01-30. Estimated completion is 2017-12-15.
What interventions are being tested in trial NCT03031457?
The interventions under investigation include: Duplex ultrasound (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03031457?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
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