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

December 16, 2014 updated by: Yaron Shargall, McMaster University

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

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 Overview

Status

Completed

Conditions

Detailed Description

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%. The latest American College of Chest Physicians (ACCP) guidelines on VTE prevention clearly outlines the perioperative thromboprophylaxis regiments for specific surgical populations. Specifically for patients undergoing orthopaedic procedures, such as total hip replacement, there is strong Grade 1A evidence for the use of extended thromboprophylaxis. For other surgical subgroups such as vascular and thoracic surgery, the evidence is less clear.

Therefore 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. Prolonged thromboprophylaxis in orthopaedic surgery beyond 10 days and up to 35 days has become the standard of care and has Grade 1A recommendations from ACCP. This approach has never been tested or validated in thoracic surgery, where major lung resection exposes the patient to an increased VTE risk not only due to the surgical stress and existence of malignancy, but also due to direct in-situ vascular injury secondary to resection of pulmonary arterial branches during the lung resection. Hence, 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 DVT and pulmonary embolus (PE) after those major lung resections.

The study will involve patients undergoing sub-lobar resection, lobectomy, bilobectomy or pneumonectomy for lung cancer or metastatic lung disease at St. Joseph's Healthcare Hamilton, a regional tertiary thoracic surgery program with more than 350 major lung resections performed within the institution annually, as well as the University Health Network's Toronto General Hospital. The study will evaluate the incidence of post-operative venous thromboembolism (VTE) and 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 an 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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital (UHN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adults of at least 18 years of age who are to undergo sub-lobar resection, lobectomy, bilobectomy or pneumonectomy for lung cancer or metastatic lung disease will be offered the opportunity to participate in the study. The inclusion criteria are intentionally broad to increase the generalizability of the study. Eligibility criteria will be considered for enrollment in the study and are listed in the methodology section. The study population for both phases one and two of the study will have the same inclusion and exclusion criteria but will not include the same participants.

Description

Patient Inclusion Criteria

  • At least 18 years of age
  • Either gender
  • Diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy
  • Undergoing one of the following surgeries: Segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy
  • Competent to understand and sign consent documents

Patient Exclusion Criteria

  • Known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH)
  • Under current anticoagulation for venous thromboembolism or other medical conditions
  • Known renal impairment, defined as creatinine clearance value of less than 55ml/min/m2 as calculated by the Cockroft-Gault method
  • History of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites
  • Pregnant or planning to become pregnant
  • Diagnosed or treated for VTE in the past 3 months prior to surgery
  • Present or previous increase risk of haemorrhage
  • History of previous HIT (heparin induced thrombocytopenia)
  • Platelet count must be below 75,000
  • Previously inserted Inferior Vena Cava Filter (IVC) filter.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the incidence of PE/DVT after lung resection for malignancies
Time Frame: 30 days post hospital discharge
30 days post hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS
Time Frame: 30 days post hospital discharge
30 days post hospital discharge
Complications and mortality of DVT and PE post lung resection
Time Frame: 30 days post hospital discharge
30 days post hospital discharge
Risk factors for the development of VTE post lung resection
Time Frame: 30 days post hospital discharge
30 days post hospital discharge
Correlation between DVT and PE in patients developing PE
Time Frame: 30 days post hospital discharge
In this specific population, many PE events might not be initiated by VTE, but rather by the result of in-situ arterial injury such as division, tying and/or clamping of the pulmonary artery branches during the lung resection. As a result, we postulate that we might identify patients with PE without a preceding DVT.
30 days post hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Heart and Stroke Foundation of Canada
Toronto General Hospital

Investigators

  • Principal Investigator: Yaron Shargall, MD BSc, St. Joseph's Healthcare Hamilton

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 8, 2014

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJHH_VTEincidence
  • 13-368 (Other Identifier: Hamilton Integrated Research Ethics Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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