[Ortho] Профилактика тромбозов - низкомолекулярный гепарин не эффективнее плацебо при переломах костей голени

[Alexander Chelnokov]

Low incidence of clinically important VTE observed after lower leg fractures

Researchers found a low overall incidence of clinically important venous 
thromboembolism after the surgical repair of isolated tibia, fibula and 
ankle fractures, with no differences reported between patients who 
received dalteparin or placebo.



Two hundred sixty-five patients who required surgery for isolated 
lower-leg fractures were included in the multicenter, double-blind study 
and randomly assigned to either 5,000 units of subcutaneous dalteparin 
or matching placebo once daily for 2 weeks. Bilateral Doppler ultrasound 
(DUS) of patients’  proximal leg veins was performed at approximately 14 
days postoperatively and at 3-month follow-up. The study’s primary 
effectiveness outcome was clinically important venous thromboembolism 
(CIVTE), or the composite of symptomatic venous thromboembolism (VTE) 
within 3 months postoperatively, as well as asymptomatic proximal deep 
vein thrombosis (DVT) on DUS. Major bleeding was considered the study’s 
primary safety outcome.



At 6-week and 3-month follow-up, the researchers assessed clinical 
status, unscheduled hospital visits or physician visits, symptoms for 
possible VTE, cointervention, bleeding and other adverse events through 
phone interviews. Objective diagnostic tests and prespecified diagnostic 
algorithms were used to investigate any clinical suspicion of DVT or 
pulmonary embolism during the 3-month study period, as well.



Of the 258 patients included as part of the analysis for primary outcome 
effectives, 130 patients had been assigned to dalteparin and 128 
patients to placebo. There were two patients who received placebo who 
had talus and calcaneal fractures, and one patient who received 
dalteparin who had a patellar fracture.



CIVTE developed in only five patients total, two of whom received 
dalteparin and three of whom received placebo. Among the events, two 
were asymptomatic DVT detected on DUS at day 14—  one in each treatment 
group. Additionally, one case of symptomatic proximal DVT occurred in 
each treatment group, detected by DUS on day 11 in the placebo group and 
on day 17 in the dalteparin group. One asymptomatic, nonfatal pulmonary 
embolism occurred in the placebo group on day 11, and whole-leg DUS, 
which was performed as protocol violations, detected calf vein thrombi 
in three patients, according to the researchers. No fatal pulmonary 
emboli or cases of major bleeding were reported.–  by Monica Jaramillo



Disclosures: Selby reports she is a consultant for Bayer, Boehringer 
Ingelheim, BMS/Pfizer, and Instrumentation Laboratory and has previously 
received grants from Boehringer Ingelheim and Bayer as well as payments 
for lectures from BMS/Pfizer.  Please see the full study for a list of 
all other authors; financial disclosures.

Источник: http://goo.gl/yKRy08

Alexander Chelnokov