Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Pulmonary Embolism | — | UNRESOLVED | — |
| Venous Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the incidence of PE/DVT after lung resection for malignancies
- timeFrame
- 30 days post hospital discharge
Secondary outcomes (4)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (24)
- BACKGROUNDGeerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656. PMID 18574271
- BACKGROUNDDaddi G, Milillo G, Lupattelli L, Ragusa M, Lemmi A, Puma F, Agnelli G; Pulmonary Embolism in Thoracic Surgery Study Group. Postoperative pulmonary embolism detected with multislice computed tomography in lung surgery for cancer. J Thorac Cardiovasc Surg. 2006 Jul;132(1):197-8. doi: 10.1016/j.jtcvs.2006.03.036. No abstract available. PMID 16798341
- BACKGROUNDKalweit G, Huwer H, Volkmer I, Petzold T, Gams E. Pulmonary embolism: a frequent cause of acute fatality after lung resection. Eur J Cardiothorac Surg. 1996;10(4):242-6; discussion 246-7. doi: 10.1016/s1010-7940(96)80146-1. PMID 8740059
- BACKGROUNDDentali F, Malato A, Ageno W, Imperatori A, Cajozzo M, Rotolo N, Douketis J, Siragusa S, Crowther M. Incidence of venous thromboembolism in patients undergoing thoracotomy for lung cancer. J Thorac Cardiovasc Surg. 2008 Mar;135(3):705-6. doi: 10.1016/j.jtcvs.2007.10.036. No abstract available. PMID 18329505
- BACKGROUNDZiomek S, Read RC, Tobler HG, Harrell JE Jr, Gocio JC, Fink LM, Ranval TJ, Ferris EJ, Harshfield DL, McFarland DR, et al. Thromboembolism in patients undergoing thoracotomy. Ann Thorac Surg. 1993 Aug;56(2):223-6; discussion 227. doi: 10.1016/0003-4975(93)91151-c. PMID 8347002
- BACKGROUNDSaarinen J, Kallio T, Sisto T, Tarkka M. Incidence of deep venous thrombosis after thoracotomy. Vasa. 2001 Nov;30(4):259-61. doi: 10.1024/0301-1526.30.4.259. PMID 11771209
- BACKGROUNDCade JF, Clegg EA, Westlake GW. Prophylaxis of venous thrombosis after major thoracic surgery. Aust N Z J Surg. 1983 Aug;53(4):301-4. doi: 10.1111/j.1445-2197.1983.tb02451.x.