Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial
Yaseen Arabi,
Fahad Al-Hameed,
Karen E. A. Burns,
Sangeeta Mehta,
Sami Alsolamy,
Mohammed Almaani,
Yasser Mandourah,
Ghaleb A. Almekhlafi,
Ali Al Bshabshe,
Simon Finfer,
Mohammed Alshahrani,
Imran Khalid,
Yatin Mehta,
Atul Gaur,
Hassan Hawa,
Hergen Buscher,
Zia Arshad,
Hani Lababidi,
Abdulsalam Al Aithan,
Jesna Jose,
Sheryl Ann I. Abdukahil,
Lara Y. Afesh,
Maamoun Dbsawy,
Abdulaziz Al-Dawood,
the PREVENT trial Group
Affiliations
Yaseen Arabi
King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
Fahad Al-Hameed
Department of Intensive Care, College of Medicine-Jeddah, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
Karen E. A. Burns
Interdepartmental Division of Critical Care Medicine, St Michael’s Hospital, Li Ka Shing Knowledge Institute
Sangeeta Mehta
Interdepartmental Division of Critical Care Medicine, Mount Sinai Hospital
Sami Alsolamy
King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
Mohammed Almaani
Department of Pulmonary and Critical Care Medicine, King Fahad Medical City, King Saud Bin Abdulaziz University for Health Sciences
Yasser Mandourah
Department of Intensive Care Services, Prince Sultan Military Medical City
Ghaleb A. Almekhlafi
Department of Intensive Care Services, Prince Sultan Military Medical City
Ali Al Bshabshe
Department of Critical Care Medicine, King Khalid University, Asir Central Hospital
Simon Finfer
Intensive Care, Royal North Shore Hospital and The George Institute for Global Health, University of New South Wales
Mohammed Alshahrani
Department of Emergency and Critical Care, Imam Abdulrahman Bin Faisal University
Imran Khalid
Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center
Yatin Mehta
Institute of Critical Care and Anaesthesiology, Medanta – The Medicity
Atul Gaur
Intensive Care Department, Gosford Hospital
Hassan Hawa
Critical Care Medicine Department, King Faisal Specialist Hospital and Research Centre
Hergen Buscher
Intensive Care Medicine, St. Vincent’s Hospital
Zia Arshad
Department of Anesthesiology and Critical Care, King George’s Medical University
Hani Lababidi
Department of Pulmonary and Critical Care Medicine, King Fahad Medical City
Abdulsalam Al Aithan
Intensive Care and Pulmonary Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
Jesna Jose
King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
Sheryl Ann I. Abdukahil
King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
Lara Y. Afesh
King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
Maamoun Dbsawy
King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
Abdulaziz Al-Dawood
King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center
Abstract Background 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. Methods/design 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%. Discussion 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. Trial registration ClinicalTrials.gov, ID: NCT02040103. Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506. Registered on 30 October 2013.
