Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against DVT and PE in Patients Undergoing Major Lung Resection
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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Ontario
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Hamilton、Ontario、加拿大、L8N 4A6
- St. Joseph's Healthcare Hamilton
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Toronto、Ontario、加拿大、M5G 2C4
- Toronto General Hospital (UHN)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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To determine the incidence of PE/DVT after lung resection for malignancies
大体时间:30 days post hospital discharge
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30 days post hospital discharge
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS
大体时间:30 days post hospital discharge
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30 days post hospital discharge
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Complications and mortality of DVT and PE post lung resection
大体时间:30 days post hospital discharge
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30 days post hospital discharge
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Risk factors for the development of VTE post lung resection
大体时间:30 days post hospital discharge
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30 days post hospital discharge
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Correlation between DVT and PE in patients developing PE
大体时间:30 days post hospital discharge
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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.
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30 days post hospital discharge
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合作者和调查者
调查人员
- 首席研究员:Yaron Shargall, MD BSc、St. Joseph's Healthcare Hamilton
出版物和有用的链接
一般刊物
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- Hull RD, Pineo GF, Stein PD, Mah AF, MacIsaac SM, Dahl OE, Butcher M, Brant RF, Ghali WA, Bergqvist D, Raskob GE. Extended out-of-hospital low-molecular-weight heparin prophylaxis against deep venous thrombosis in patients after elective hip arthroplasty: a systematic review. Ann Intern Med. 2001 Nov 20;135(10):858-69. doi: 10.7326/0003-4819-135-10-200111200-00006.
- Bergqvist D, Benoni G, Bjorgell O, Fredin H, Hedlundh U, Nicolas S, Nilsson P, Nylander G. Low-molecular-weight heparin (enoxaparin) as prophylaxis against venous thromboembolism after total hip replacement. N Engl J Med. 1996 Sep 5;335(10):696-700. doi: 10.1056/NEJM199609053351002.
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- Hurwitz LM, Yoshizumi TT, Goodman PC, Nelson RC, Toncheva G, Nguyen GB, Lowry C, Anderson-Evans C. Radiation dose savings for adult pulmonary embolus 64-MDCT using bismuth breast shields, lower peak kilovoltage, and automatic tube current modulation. AJR Am J Roentgenol. 2009 Jan;192(1):244-53. doi: 10.2214/AJR.08.1066.
- Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in inpatients undergoing surgery. National Institute for Health and Clinical Excellence (NICE). 2010
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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