Venous ThrombosisNCT02258958
Extended Out-of-hospital Low-molecular-weight Heparin Prophylaxis Against DVT and PE in Patients Undergoing Major Lung Resection
An observational study of Venous Thrombosis and Pulmonary Embolism, run by McMaster University at 2 sites in Canada.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thrombosis, Pulmonary Embolism, Lung Neoplasms
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Toronto General Hospital (UHN)
Toronto, Ontario, M5G 2C4
About this study
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
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.
Read the 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.
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Lung Neoplasms
- Keywords
- venous thromboembolism prophylaxis, deep venous thrombosis, pulmonary embolus, thoracic surgery, lung resection, incidence
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the incidence of PE/DVT after lung resection for malignancies
Measured: 30 days post hospital discharge
Secondary outcomes (4)
Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS
Measured: 30 days post hospital discharge
Complications and mortality of DVT and PE post lung resection
Measured: 30 days post hospital discharge
Risk factors for the development of VTE post lung resection
Measured: 30 days post hospital discharge
Correlation between DVT and PE in patients developing PE
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.
Measured: 30 days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto General Hospital, Heart and Stroke Foundation of Canada
- Responsible party
- Principal investigator, Yaron Shargall, McMaster University
- Investigators
- Yaron Shargall, MD BSc, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02258958
- Sponsor's protocol ID
- SJHH_VTEincidence
- Other IDs
- 13-368
- Status last verified
- Dec 2014
- First submitted
- 3 Oct 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Geerts 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.
PubMed 18574271Daddi 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.
PubMed 16798341Kalweit 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.
PubMed 8740059Dentali 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.
PubMed 18329505Ziomek 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.
PubMed 8347002Saarinen 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.
PubMed 11771209Cade 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.
PubMed 6577843Azorin JF, Regnard JF, Dahan M, Pansart M. [Efficacy and tolerability of fraxiparine in the prevention of thromboembolic complications in oncologic thoracic surgery]. Ann Cardiol Angeiol (Paris). 1997 May-Jun;46(5-6):341-7. French.
PubMed 9295896Hull 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.
PubMed 11712876Bergqvist 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.
PubMed 8703168Planes A, Vochelle N, Darmon JY, Fagola M, Bellaud M, Huet Y. Risk of deep-venous thrombosis after hospital discharge in patients having undergone total hip replacement: double-blind randomised comparison of enoxaparin versus placebo. Lancet. 1996 Jul 27;348(9022):224-8. doi: 10.1016/s0140-6736(96)01453-5.
PubMed 8684199Comp PC, Spiro TE, Friedman RJ, Whitsett TL, Johnson GJ, Gardiner GA Jr, Landon GC, Jove M; Enoxaparin Clinical Trial Group. Prolonged enoxaparin therapy to prevent venous thromboembolism after primary hip or knee replacement. Enoxaparin Clinical Trial Group. J Bone Joint Surg Am. 2001 Mar;83(3):336-45. doi: 10.2106/00004623-200103000-00004.
PubMed 11263636Hull RD, Pineo GF, Francis C, Bergqvist D, Fellenius C, Soderberg K, Holmqvist A, Mant M, Dear R, Baylis B, Mah A, Brant R. Low-molecular-weight heparin prophylaxis using dalteparin extended out-of-hospital vs in-hospital warfarin/out-of-hospital placebo in hip arthroplasty patients: a double-blind, randomized comparison. North American Fragmin Trial Investigators. Arch Intern Med. 2000 Jul 24;160(14):2208-15. doi: 10.1001/archinte.160.14.2208.
PubMed 10904465Lassen MR, Borris LC, Anderson BS, Jensen HP, Skejo Bro HP, Andersen G, Petersen AO, Siem P, Horlyck E, Jensen BV, Thomsen PB, Hansen BR, Erin-Madsen J, Moller JC, Rotwitt L, Christensen F, Nielsen JB, Jorgensen PS, Paaske B, Torholm C, Hvidt P, Jensen NK, Nielsen AB, Appelquist E, Tjalve E, et al. Efficacy and safety of prolonged thromboprophylaxis with a low molecular weight heparin (dalteparin) after total hip arthroplasty--the Danish Prolonged Prophylaxis (DaPP) Study. Thromb Res. 1998 Mar 15;89(6):281-7. doi: 10.1016/s0049-3848(98)00018-8.
PubMed 9669750White RH, Romano PS, Zhou H, Rodrigo J, Bargar W. Incidence and time course of thromboembolic outcomes following total hip or knee arthroplasty. Arch Intern Med. 1998 Jul 27;158(14):1525-31. doi: 10.1001/archinte.158.14.1525.
PubMed 9679793
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02258958
- Acronym / sponsor ID
- SJHH_VTEincidence
- Conditions
- Venous Thrombosis, Pulmonary Embolism, Lung Neoplasms
- Keywords
- venous thromboembolism prophylaxis, deep venous thrombosis, pulmonary embolus, thoracic surgery, lung resection, incidence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Toronto General Hospital, Heart and Stroke Foundation of Canada
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the incidence of PE/DVT after lung resection for malignancies
Time frame: 30 days post hospital discharge
4 secondary outcomes
Incidence of post-operative PE and DVT comparing thoracotomy vs. VATS
Time frame: 30 days post hospital discharge
Complications and mortality of DVT and PE post lung resection
Time frame: 30 days post hospital discharge
Risk factors for the development of VTE 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Background: PubMed 18574271Geerts 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.
- Background: PubMed 16798341Daddi 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.
- Background: PubMed 8740059Kalweit 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.
- Background: PubMed 18329505Dentali 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.
- Background: PubMed 8347002Ziomek 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.
- Background: PubMed 11771209Saarinen 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.
- Background: PubMed 6577843Cade 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.
- Background: PubMed 9295896Azorin JF, Regnard JF, Dahan M, Pansart M. [Efficacy and tolerability of fraxiparine in the prevention of thromboembolic complications in oncologic thoracic surgery]. Ann Cardiol Angeiol (Paris). 1997 May-Jun;46(5-6):341-7. French.
- Background: PubMed 11712876Hull 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.
- Background: PubMed 8703168Bergqvist 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.
- Background: PubMed 8684199Planes A, Vochelle N, Darmon JY, Fagola M, Bellaud M, Huet Y. Risk of deep-venous thrombosis after hospital discharge in patients having undergone total hip replacement: double-blind randomised comparison of enoxaparin versus placebo. Lancet. 1996 Jul 27;348(9022):224-8. doi: 10.1016/s0140-6736(96)01453-5.
- Background: PubMed 11263636Comp PC, Spiro TE, Friedman RJ, Whitsett TL, Johnson GJ, Gardiner GA Jr, Landon GC, Jove M; Enoxaparin Clinical Trial Group. Prolonged enoxaparin therapy to prevent venous thromboembolism after primary hip or knee replacement. Enoxaparin Clinical Trial Group. J Bone Joint Surg Am. 2001 Mar;83(3):336-45. doi: 10.2106/00004623-200103000-00004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Shargall, MD BSc principal investigator
St. Joseph's Healthcare Hamilton
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thrombosis and Pulmonary Embolism, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the incidence of PE/DVT after lung resection for malignancies (time frame: 30 days post hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02258958, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.