02631nas a2200409   4500000000100000008004100001100001700042700001700059700001900076700001600095700002400111700002000135700001800155700002100173700002100194700002200215700001700237700001700254700001600271700001400287700001600301700001900317700001500336700001800351700002200369700001500391700002100406700001500427700001900442700002400461700002400485245016700509300000800676490000700684520151600691022001402207       2018                            d1 aFinfer Simon1 aArabi Yaseen1 aMehta Sangeeta1 aBurns Karen1 aAlshahrani Mohammed1 aAl-Hameed Fahad1 aAlsolamy Sami1 aAlmaani Mohammed1 aMandourah Yasser1 aAlmekhlafi Ghaleb1 aBshabshe Ali1 aKhalid Imran1 aMehta Yatin1 aGaur Atul1 aHawa Hassan1 aBuscher Hergen1 aArshad Zia1 aLababidi Hani1 aAithan Abdulsalam1 aJose Jesna1 aAbdukahil Sheryl1 aAfesh Lara1 aDbsawy Maamoun1 aAl-Dawood Abdulaziz1 aPREVENT trial Group00aStatistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.  a1820 v193 a<p><b>BACKGROUND: </b>The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults.</p><p><b>METHODS/DESIGN: </b>In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%.</p><p><b>DISCUSSION: </b>Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data.</p><p><b>TRIAL REGISTRATION: </b>ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.</p>  a1745-6215