Clinical trial NCT02258958: Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against DVT and PE in Patients Undergoing Major Lung Resection
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis
Pulmonary Embolism
Lung Neoplasms
Keywords: venous thromboembolism prophylaxis
deep venous thrombosis
pulmonary embolus
thoracic surgery
lung resection
incidence
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Toronto General Hospital
name: Heart and Stroke Foundation of Canada
First posted: 2014-10-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: To determine the incidence of PE/DVT after lung resection for malignancies
timeFrame: 30 days post hospital discharge
Secondary outcomes:
measure: Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS
timeFrame: 30 days post hospital discharge
measure: Complications and mortality of DVT and PE post lung resection
timeFrame: 30 days post hospital discharge
measure: Risk factors for the development of VTE post lung resection
timeFrame: 30 days post hospital discharge
measure: Correlation between DVT and PE in patients developing PE
timeFrame: 30 days post hospital discharge
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital (UHN)
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare Hamilton
name: Yaron Shargall, MD BSc
role: PRINCIPAL_INVESTIGATOR
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