Related ACE Reports
- Published: Nov 2016
- ACE Report #9438
Routine thromboprophylaxis not necessary in treatment of patients with foot/ankle fracture
Study Type: Therapy
OE Level of Evidence: 2
Journal Level of Evidence: 1
|Sponsor:||Key Program of Science and Technique Development; Peak Talents Foundation; China Postdoctoral Science Foundation; Medical Science and Technology Development Foundation|
Why was this study needed now?
The treatment of lower-extremity fractures, particularly those occurring in the ankle or foot, typically requires a period of immobilization, which can place patients at greater risk of developing venous thromboembolic complications. Currently, there is controversy regarding the routine use of chemical prophylaxis and its effectiveness in reducing the incidence of VTE complications following fixation of fractures in the ankle or foot. A large randomized controlled trial was needed to improve the evidence available to make recommendations regarding the use of thromboprophylaxis in those with ankle or foot fracture.
What was the principal research question?
Does chemical thromboprophylaxis with low molecular weight heparin significantly reduce the incidence of venous thromboembolic complications in patients undergoing operative fixation of an ankle or foot fracture when compared to patients administered saline?
|Population:||814 patients, over the age of 18 years, with unilateral or bilateral, open or closed fractures of the ankle or foot requiring operative fixation were included. Patients with associated upper body injury, concurrent tibial, fibular, femoral, or hip fracture, history of thromboembolic events, requiring anticoagulation therapy or with known hypercoagulation disorders were excluded.|
|Intervention:||LMWH group: Patients were administered subcutaneous low molecular weight heparin once daily for 14 days, beginning immediately after randomization. (n=411; Mean age: 45.7+/-15.7)|
|Comparison:||Placebo group: Patients were administered subcutaneous saline once daily for 14 days, beginning immediately after randomization. (n=403; Mean age: 46.4+/-16.0)|
|Outcomes:||The primary outcome was the incidence of symptomatic or asymptomatic deep vein thrombosis or pulmonary embolism, confirmed using bilateral Doppler ultrasound. Incidents of minor and major bleeding were also documented.|
|Time:||Routine imaging was scheduled for 1 day preoperatively, 1 week postoperatively, and 1 month postoperatively.|
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.