CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02258958
NCT02258958N/ACompleted

Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against Deep Venous Thrombosis and Pulmonary Embolus in Patients Undergoing Major Lung Resection: A Pilot Study to Evaluate the Incidence of DVT and PE After Major Lung Resection

McMaster University·observational·Posted Oct 8, 2014·Updated Dec 18, 2014

In Brief

An observational study for Venous Thrombosis and 2 related conditions. Completed, enrolled 150 participants across 2 sites.

Detailed Summary

Postoperative venous thromboembolism (VTE) is a significant health-care problem, resulting in significant morbidity, mortality and resource utilization. The true incidence is unknown, and may range from 1% to 15%. At the current time, the clinical practice of VTE prophylaxis in thoracic surgery includes administration of unfractionated or low molecular weight heparin starting at the perioperative period and finishing at the time of patients' discharge. In orthopaedic surgery, prolonged thromboprophylaxis beyond 10 days and up to 35 days has become the standard of care. There is a clear need to systematically evaluate the incidence of VTE after resection of lung malignancies and to evaluate the role of extended VTE prophylaxis in preventing Deep Vein Thrombosis (DVT) and pulmonary embolus (PE) after those major lung resections. This study will involve patients undergoing lung resection for malignancy at St. Joseph's Healthcare Hamilton and the University Health Network's Toronto General Hospital. The study will include 150 consecutively recruited patients. Study interventions will include Computed Tomography with pulmonary embolus (PE) protocol and bilateral extended leg Doppler Ultrasound for the detection of Deep Vein Thrombosis 30 days post-surgery. In summary, this study is aimed at evaluating, for the first time in a prospective manner, the actual incidence of DVT and PE in patients undergoing major lung resections for malignancies. The knowledge gained in this study will be used to inform a future investigation involving a Randomized Controlled Trial (RCT) to compare current post-operative thromboprophylaxis with an extended 30-day prophylaxis protocol with the hope of providing an evidence-based practice change in VTE prophylaxis care for this high risk population.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 8, 2014
Enrollment StartJan 1, 2014
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 11.7 years ago