Qualitative analysis of randomized controlled trials informing recommendations for venous thromboembolism prophylaxis after distal lower extremity injuries.

Purpose: The purpose of this study is to assess the quality of evidence to stratify recommendations for chemoprophylaxis following distal lower extremity trauma. Methods: Literature review identified primary studies investigating venous thromboembolism (VTE) chemoprophylaxis following traumatic injury distal to the knee. Inclusion criteria were randomized controlled trials in adult patients treated with and without operative intervention. Each primary study was assessed by the Consolidated Standards of Reporting Trials 2010 checklist and Modified Coleman methodology score. Results: Literature review resulted in 462 studies, of which 9 met inclusion and exclusion criteria. All studies included low molecular weight heparin as a treatment group with 2 (22%) also including a treatment group with a direct factor Xa inhibitor. Five studies (56%) used placebo as a control group. The mean Modified Coleman Methodology score was 63% (range 51%-72%), a categorical rating of Fair. The mean Consolidated Standards of Reporting Trials score was 78% (range 56%-97%). Most studies (89%) screened all asymptomatic subjects for deep venous thrombosis. Statistical significance in VTE incidence among prophylactic treatment groups was not achieved in 78%. Conclusions: Development of consensus for VTE prophylaxis recommendations following traumatic injury distal to the knee is complicated by heterogenous study populations, low incidence of VTE in study populations, and inconsistent definitions of clinically important VTE. Low molecular weight heparin is not consistently superior for preventing VTE. Chemoprophylaxis should be considered on an individual basis in the presence of additional risk factors, although an externally validated, evidence-based risk assessment tool does not currently exist.