Status:
COMPLETED
The D-KAF (Dalteparin in Knee-to-Ankle Fracture) Trial
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Pfizer
Conditions:
Deep Vein Thrombosis
Pulmonary Embolism
Eligibility:
All Genders
16+ years
Phase:
PHASE4
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...
Detailed Description
RESEARCH QUESTIONS 1. What is the incidence of clinically-important venous thromboembolism (VTE) following surgically-repaired, isolated fractures of the tibia, fibula or ankle? 2. In patients with s...
Eligibility Criteria
Inclusion
- Age \> 16 years
- Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including:
- Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus
- Isolated fractures of the fibula including fibular head, fibular diaphysis,distal fibula and lateral malleolus
- 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
- 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
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
January 1 2007
Estimated Enrollment :
700 Patients enrolled
Trial Details
Trial ID
NCT00187408
Start Date
August 1 2002
End Date
January 1 2007
Last Update
February 27 2007
Active Locations (13)
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1
2E3.32 Walter MacKenzie HSC
Edmonton, Alberta, Canada, TG6 2R7
2
St. Paul's Hospital-Providence Health Care
Vancouver, British Columbia, Canada, V6Z 1Y6
3
Hamilton Health Sciences- General Site
Hamilton, Ontario, Canada, L8L 2X2
4
McMaster University Medical Centre, HSC
Hamilton, Ontario, Canada, L8N 3Z5