Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial

Trials

the PREVENT trial Group¹  Hassan Hawa²  Imran Khalid³  Zia Arshad⁴  Ali Al Bshabshe⁵  Mohammed Alshahrani⁶  Yasser Mandourah⁷  Ghaleb A. Almekhlafi⁷  Fahad Al-Hameed⁸  Mohammed Almaani⁹  Hani Lababidi^1,10  Yatin Mehta^1,11  Atul Gaur^1,12  Hergen Buscher^1,13  Abdulsalam Al Aithan^1,14  Simon Finfer^1,15  Sangeeta Mehta^1,16  Karen E. A. Burns^1,17  Yaseen Arabi^1,18  Sami Alsolamy^1,18  Jesna Jose^1,18  Lara Y. Afesh^1,18  Abdulaziz Al-Dawood^1,18  Maamoun Dbsawy^1,18  Sheryl Ann I. Abdukahil^1,18 

[1] ;Critical Care Medicine Department, King Faisal Specialist Hospital and Research Centre;Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center;Department of Anesthesiology and Critical Care, King George’s Medical University;Department of Critical Care Medicine, King Khalid University, Asir Central Hospital;Department of Emergency and Critical Care, Imam Abdulrahman Bin Faisal University;Department of Intensive Care Services, Prince Sultan Military Medical City;Department of Intensive Care, College of Medicine-Jeddah, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center;Department of Pulmonary and Critical Care Medicine, King Fahad Medical City, King Saud Bin Abdulaziz University for Health Sciences;Department of Pulmonary and Critical Care Medicine, King Fahad Medical City;Institute of Critical Care and Anaesthesiology, Medanta – The Medicity;Intensive Care Department, Gosford Hospital;Intensive Care Medicine, St. Vincent’s Hospital;Intensive Care and Pulmonary Medicine, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center;Intensive Care, Royal North Shore Hospital and The George Institute for Global Health, University of New South Wales;Interdepartmental Division of Critical Care Medicine, Mount Sinai Hospital;Interdepartmental Division of Critical Care Medicine, St Michael’s Hospital, Li Ka Shing Knowledge Institute;King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center;

关键词: Deep vein thrombosis;    Pulmonary embolism;    Intermittent pneumatic compression;    Adjunct mechanical and pharmacologic DVT prophylaxis;    Critically-ill patients;   

DOI  :  10.1186/s13063-018-2534-6

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown