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Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against DVT and PE in Patients Undergoing Major Lung Resection

NCT02258958 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2014-12-18

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • Toronto General Hospital

    collaborator OTHER

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • Yaron Shargall, MD BSc · St. Joseph's Healthcare Hamilton

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Canada

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02258958 on ClinicalTrials.gov