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

NCT02258958 | Completed

• 2 other identifiers: SJHH_VTEincidence13-368
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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

Venous Thrombosis; Pulmonary Embolism; Lung Neoplasms

Keywords

venous thromboembolism prophylaxis; deep venous thrombosis; pulmonary embolus; thoracic surgery; lung resection; incidence

Outcome Measures

Primary Outcomes (1)

• To determine the incidence of PE/DVT after lung resection for malignancies

  30 days post hospital discharge

Secondary Outcomes (4)

• Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS

  30 days post hospital discharge

• Complications and mortality of DVT and PE post lung resection

  30 days post hospital discharge

• Risk factors for the development of VTE post lung resection

  30 days post hospital discharge

• Correlation between DVT and PE in patients developing PE

  30 days post hospital discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• Toronto General Hospital: collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Toronto General Hospital (UHN)

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (24)

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  BACKGROUND

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism; Lung Neoplasms

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Yaron Shargall, MD BSc

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Services Thoracic Surgery

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 8, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

CA (2)