ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Edmonton, Alberta
- Vancouver, British Columbia
- Hamilton, Ontario
- Hamilton, Ontario
- Hamilton, Ontario
- Hamilton, Ontario
- Ottawa, Ontario
- Ottawa, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Montreal, Quebec
- Nagakute, Aichi
- Sakura, Chiba
- Kitakyusyu, Fukuoka
- Hatsukaichi, Hiroshima
- Sapporo, Hokkaido
- Kahoku-gun, Ishikawa
- Yokohama, Kanagawa
- Yokohama, Kanagawa
- Tsu, MIE
- Okayama City, Okayama
- Osakasayama, Osaka
- Suita-shi, Osaka
- Chuo-ku, Tokyo
- Itabashi-ku, Tokyo
- Meguro-ku, Tokyo
- Musashino, Tokyo
- Shinjuku-ku, Tokyo
- Fukushima,
- Kumamoto,
- Kumamoto,
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | The D-KAF (Dalteparin in Knee-to-Ankle Fracture) Trial | ||||||
Official Title ICMJE | Clinically-Important Venous Thromboembolism Following Lower Extremity Fractures: Epidemiology & Prevention | ||||||
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. | ||||||
Detailed Description | RESEARCH QUESTIONS
| ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention | ||||||
Condition ICMJE |
| ||||||
Intervention ICMJE | Drug: Low Molecular Weight Heparin (dalteparin) | ||||||
Study Arms ICMJE | Not Provided | ||||||
Publications * |
| ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Enrollment ICMJE | 700 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Study Completion Date ICMJE | January 2007 | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 16 Years and older (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00187408 | ||||||
Other Study ID Numbers ICMJE | 524E-CVD-0042-042 | ||||||
Has Data Monitoring Committee | Not Provided | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Not Provided | ||||||
Study Sponsor ICMJE | Sunnybrook Health Sciences Centre | ||||||
Collaborators ICMJE |
| ||||||
Investigators ICMJE |
| ||||||
PRS Account | Sunnybrook Health Sciences Centre | ||||||
Verification Date | February 2006 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |