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The D-KAF (Dalteparin in Knee-to-Ankle Fracture) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00187408
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 27, 2007
Canadian Institutes of Health Research (CIHR)
Information provided by:
Sunnybrook Health Sciences Centre

Brief Summary:
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 or disease Intervention/treatment Phase
Deep Vein Thrombosis Pulmonary Embolism Drug: Low Molecular Weight Heparin (dalteparin) Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Clinically-Important Venous Thromboembolism Following Lower Extremity Fractures: Epidemiology & Prevention
Study Start Date : August 2002
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin

Primary Outcome Measures :
  1. Clinically important venous thromboembolism at 3 months

Secondary Outcome Measures :
  1. Clinically important VTE during the prophylaxis phase
  2. Symptomatic VTE (either symptomatic DVT or PE or fatal PE) during the post-prophylaxis phase
  3. Bleeding
  4. Cost-effectiveness

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 16 years
  • Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including:

    1. Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus
    2. Isolated fractures of the fibula including fibular head, fibular diaphysis,distal fibula and lateral malleolus
    3. Combined fractures of the tibia and fibula
  • Tibia and/or fibula fractures may be accompanied by fractures of the patella and/or foot as well as ligamentous injuries as long as either the tibia or the fibula is involved
  • Patients must be scheduled to undergo surgery (internal or external fixation) for repair of their fracture during the current admission

Exclusion Criteria:

  • Patients presenting greater than 72 hours after injury
  • Major injury involving other site(s)
  • Lower extremity vascular injury requiring surgical repair
  • Known systemic bleeding disorder or INR > 1.5, aPTT > 40 sec, or platelets < 50 x 109/L at baseline
  • Active, uncontrolled bleeding (as determined by the attending surgeon or delegate)
  • Intracranial or other major bleed in the previous 4 weeks
  • Ongoing need for anticoagulation for other reasons
  • Previous DVT or PE (objectively proven or treated with anticoagulants)
  • Known molecular hypercoagulable state
  • Active cancer
  • Inability to receive contrast dye because of pregnancy, contrast allergy, or renal failure (serum creatinine > 300 mmol/L)
  • Hypersensitivity to heparin or LMWH (including history of HIT)
  • Inability to arrange out-of-hospital study medication administration
  • Anticipated inability to undergo endpoint duplex ultrasound or follow-up (day 14 ± 2, 6 weeks, 3 months)
  • Inability or refusal to provide informed consent· Previous participation in this study
  • Estimated weight less than 40 kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187408

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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
Hamilton Health Sciences- General Site
Hamilton, Ontario, Canada, L8L 2X2
McMaster University Medical Centre, HSC
Hamilton, Ontario, Canada, L8N 3Z5
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Sciences-Henderson Site
Hamilton, Ontario, Canada, L8V 1C3
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada, K1Y 4E9
North York General Hospital-General Site
Toronto, Ontario, Canada, M2K 1E1
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
McGill University Health Centre-Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00187408    
Other Study ID Numbers: 524E-CVD-0042-042
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 27, 2007
Last Verified: February 2006
Keywords provided by Sunnybrook Health Sciences Centre:
Pulmonary Embolism
Low Molecular Weight Heparin
Tibial Fractures
Additional relevant MeSH terms:
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Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action