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Sponsors and Collaborators: |
Sunnybrook Health Sciences Centre Canadian Institutes of Health Research (CIHR) Pfizer |
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Information provided by: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT00187408 |
It is known that patients who fracture their legs sometimes develop blood clots (known as deep vein thrombosis) in their legs. These clots may cause pain and swelling in the leg or they may detach and travel to the lungs producing shortness of breath, chest pain, and sometimes death. Unfortunately, it is not known how frequently these complications occur after leg fractures, or if the use of a blood thinner medication can effectively and safely prevent these clots. Doctors at hospitals across Canada are conducting a study in which patients who have surgery for leg fractures receive either a once-daily injection of a blood thinner, known as low molecular weight heparin, or a placebo injection for up to 14 days after their fractures. Neither the patients nor the doctors know which patient is on the medication and which patient is on placebo. All patients receive an ultrasound examination of their legs at 2 weeks after surgery to monitor for deep vein thrombosis. In addition, all patients are checked for symptoms of leg or lung clots and any side effects of the medication for 3 months. If the blood thinner is shown to be effective at reducing this complication and documented to be safe and cost-effective in this setting it will be recommended for use in such patients. If, on the other hand, the frequency of deep vein thrombosis is too low to justify the cost or inconvenience of taking this medication, this will also be an important finding.
Condition | Intervention | Phase |
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Deep Vein Thrombosis Pulmonary Embolism |
Drug: Low Molecular Weight Heparin (dalteparin) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Clinically-Important Venous Thromboembolism Following Lower Extremity Fractures: Epidemiology & Prevention |
Estimated Enrollment: | 700 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | January 2007 |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including:
Exclusion Criteria:
Canada, Alberta | |
2E3.32 Walter MacKenzie HSC | |
Edmonton, Alberta, Canada, TG6 2R7 | |
Canada, British Columbia | |
St. Paul’s Hospital-Providence Health Care | |
Vancouver, British Columbia, Canada, V6Z 1Y6 | |
Canada, Ontario | |
Sunnybrook & Women's College Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 | |
North York General Hospital-General Site | |
Toronto, Ontario, Canada, M2K 1E1 | |
St. Michael’s Hospital | |
Toronto, Ontario, Canada, M5B 1W8 | |
St. Joseph’s Healthcare Hamilton | |
Hamilton, Ontario, Canada, L8N 4A6 | |
Toronto East General Hospital | |
Toronto, Ontario, Canada, M4C 3E7 | |
Hamilton Health Sciences-Henderson Site | |
Hamilton, Ontario, Canada, L8V 1C3 | |
Ottawa Hospital – Civic Campus | |
Ottawa, Ontario, Canada, K1Y 4E9 | |
Ottawa Hospital – General Campus | |
Ottawa, Ontario, Canada, K1H 8L6 | |
McMaster University Medical Centre, HSC | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Hamilton Health Sciences- General Site | |
Hamilton, Ontario, Canada, L8L 2X2 | |
Canada, Quebec | |
McGill University Health Centre-Montreal General Hospital | |
Montreal, Quebec, Canada, H3G 1A4 |
Principal Investigator: | Rita Selby, MBBS, FRCPC | Sunnybrook & Women's College Health Sciences Centre |
Principal Investigator: | William Geerts, MD, FRCPC | Sunybrook & Women's College Health Sciences Centre |
Study ID Numbers: | 524E-CVD-0042-042 |
Study First Received: | September 13, 2005 |
Last Updated: | February 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00187408 History of Changes |
Health Authority: | Canada: Health Canada |
Thrombosis Pulmonary Embolism Low Molecular Weight Heparin Tibial Fractures |
Anticoagulants Pulmonary Embolism Heparin, Low-Molecular-Weight Fractures, Bone Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Tibial Fractures Venous Thromboembolism Thrombosis Thromboembolism |
Calcium heparin Body Weight Fibrin Modulating Agents Embolism and Thrombosis Respiratory Tract Diseases Dalteparin Embolism Lung Diseases Venous Thrombosis Heparin |
Pulmonary Embolism Anticoagulants Molecular Mechanisms of Pharmacological Action Heparin, Low-Molecular-Weight Hematologic Agents Vascular Diseases Fibrinolytic Agents Cardiovascular Agents Pharmacologic Actions Thrombosis |
Fibrin Modulating Agents Embolism and Thrombosis Respiratory Tract Diseases Embolism Dalteparin Therapeutic Uses Lung Diseases Venous Thrombosis Cardiovascular Diseases |