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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Pfizer
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187408
First received: September 13, 2005
Last updated: February 26, 2007
Last verified: February 2006
  Purpose

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
Deep Vein Thrombosis
Pulmonary Embolism
Drug: Low Molecular Weight Heparin (dalteparin)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Clinically-Important Venous Thromboembolism Following Lower Extremity Fractures: Epidemiology & Prevention

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Clinically important venous thromboembolism at 3 months

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

Estimated Enrollment: 700
Study Start Date: August 2002
Estimated Study Completion Date: January 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187408

Locations
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
St. Joseph’s Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
McMaster University Medical Centre, HSC
Hamilton, Ontario, Canada, L8N 3Z5
Hamilton Health Sciences- General Site
Hamilton, Ontario, Canada, L8L 2X2
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
St. Michael’s Hospital
Toronto, Ontario, Canada, M5B 1W8
Sunnybrook & Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
North York General Hospital-General Site
Toronto, Ontario, Canada, M2K 1E1
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
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)
Pfizer
Investigators
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00187408     History of Changes
Other Study ID Numbers: 524E-CVD-0042-042
Study First Received: September 13, 2005
Last Updated: February 26, 2007
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Thrombosis
Pulmonary Embolism
Low Molecular Weight Heparin
Tibial Fractures

Additional relevant MeSH terms:
Thrombosis
Pulmonary Embolism
Venous Thrombosis
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 30, 2014