The D-KAF (Dalteparin in Knee-to-Ankle Fracture) Trial
Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborators:
Canadian Institutes of Health Research (CIHR) Pfizer