A double-blind, randomized controlled trial of the prevention of clinically important venous thromboembolism after isolated lower leg fractures.

niversity of Toronto (Canada)0 sites700 target enrollmentFebruary 24, 2006

Overview

Phase: 未知
Intervention: Not specified
Conditions: Isolated below-knee fractures (tibia and/or fibula) requiring surgical repair
Sponsor: niversity of Toronto (Canada)
Enrollment: 700
Status: Completed
Last Updated: 7 years ago

Registry

who.int

Start Date

February 24, 2006

End Date

March 31, 2007

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Toronto (Canada)

•1\. Age \>16 years, either sex
•2\. Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including:
•a. Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus
•b. Isolated fractures of the fibula including fibular head, fibular diaphysis, distal fibula and lateral malleolus
•c. Combined fractures of the tibia and fibula
•3\. 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
•4\. Patients must be scheduled to undergo surgery (internal or external fixation) for repair of their fracture during the current admission

•1\. Patients presenting greater than 72 hours after injury
•2\. Major injury involving other site(s)
•3\. Lower extremity vascular injury requiring surgical repair
•4\. Known systemic bleeding disorder or international normalized ratio (INR) \>1\.5, aPTT \>40 sec, or platelets \<50 x 10^9/l at baseline
•5\. Active, uncontrolled bleeding (as determined by the attending surgeon or delegate)
•6\. Intracranial or other major bleed in the previous 4 weeks
•7\. Ongoing need for anticoagulation for other reasons
•8\. Previous DVT or PE (objectively proven or treated with anticoagulants)
•9\. Known molecular hypercoagulable state
•10\. Active cancer