@article{23230,
  author = {Finfer Simon and Arabi Yaseen and Mehta Sangeeta and Burns Karen and Alshahrani Mohammed and Al-Hameed Fahad and Alsolamy Sami and Almaani Mohammed and Mandourah Yasser and Almekhlafi Ghaleb and Bshabshe Ali and Khalid Imran and Mehta Yatin and Gaur Atul and Hawa Hassan and Buscher Hergen and Arshad Zia and Lababidi Hani and Aithan Abdulsalam and Jose Jesna and Abdukahil Sheryl and Afesh Lara and Dbsawy Maamoun and Al-Dawood Abdulaziz and PREVENT trial Group},
  title = {Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.},
  abstract = {<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>},
  year = {2018},
  journal = {Trials},
  volume = {19},
  pages = {182},
  issn = {1745-6215},
  doi = {10.1186/s13063-018-2534-6},
  language = {eng},
}