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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02258958
• Date of registration: 03/10/2014
• Prospective Registration: No
• Primary sponsor: McMaster University
• Public title: Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against DVT and PE in Patients Undergoing Major Lung Resection
• Scientific title: 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
• Date of first enrolment: January 2014
• Target sample size: 150
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02258958
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Yaron Shargall, MD BSc
• Affiliation: St. Joseph's Healthcare Hamilton

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Venous Thrombosis

Lung Neoplasms

Pulmonary Embolism

Primary Outcome(s)

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

Secondary Outcome(s)

Risk factors for the development of VTE post lung resection [Time Frame: 30 days post hospital discharge]

Complications and mortality of DVT and PE post lung resection [Time Frame: 30 days post hospital discharge]

Correlation between DVT and PE in patients developing PE [Time Frame: 30 days post hospital discharge]

Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS [Time Frame: 30 days post hospital discharge]

Secondary ID(s)

13-368

SJHH_VTEincidence

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Toronto General Hospital

Heart and Stroke Foundation of Canada