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, PREVENT trial Group, Yaseen Arabi, Abdulaziz Al-Dawood, Sami Alsolamy, Mohamed Hegazy, Maamoun Dbsawy, Sheryl Ann I Abdukahil, Lara Afesh, Fahad Al-Hameed, Gulam Rasool, Jalal Rifai, Ali S Mohamed, Ohoud Al Orabi, Yasser Mandourah, Ghaleb Almekhlafi, Dina Al Sufiani, Emad Al Amodi, Mohamed Alkhader, Shatha Awad, Ma Raylin Cubio Cabal, Jean S Valerio, Sahar Hassan, Bander Alanazi, Kholoud Alharbi, Ahmad Alenazy, Mohammed Alshahrani, Laila Perlas Asonto, Kathrina Libunao-de Loyola, Ali Al Bshabshe, Abdulmoniem Albahar, Ali Alamri, Abdulsalam Al Aithan, Shahinaz Bashir, Mohammed Almaani, Hani Lababidi, Husain Abdulmuthalib, Pendo Ntinika, Rachelle Pangilinan, Imran Khalid, Abdulaziz Jadkareem, Eman Bawazeer, Sawsan Bassi, Hassan Hawa, Khalid Maghrabi, Mohammad Hijazi, Musaab Abdelhai, Ellen Joy Pagunsan, Marketa Vinklerova, Sangeeta Mehta, Sumesh Shah, Erik Tamberg, Karen Burns, Orla Smith, Marlene Santos, Gyan Sandhu, Jennifer Hodder, Kurtis Salway, Michael Jacka, Lorena McCoshen, Nadia Baig, Atul Gaur, Katrina Ellis, Mary White, Rebecca Gregory, Rob Cameron, Simon Finfer, Anne O'Connor, Elizabeth Yarad, Frances Bass, Naomi Hammond, Hergen Buscher, Claire Reynolds, Karlee McCann, Zia Arshad, Sachin Kumar Srivastava, Avinash Singh, Yatin Mehta, Joby George, Chitra Mehta, Ashish Kumar, 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, PREVENT trial Group, Yaseen Arabi, Abdulaziz Al-Dawood, Sami Alsolamy, Mohamed Hegazy, Maamoun Dbsawy, Sheryl Ann I Abdukahil, Lara Afesh, Fahad Al-Hameed, Gulam Rasool, Jalal Rifai, Ali S Mohamed, Ohoud Al Orabi, Yasser Mandourah, Ghaleb Almekhlafi, Dina Al Sufiani, Emad Al Amodi, Mohamed Alkhader, Shatha Awad, Ma Raylin Cubio Cabal, Jean S Valerio, Sahar Hassan, Bander Alanazi, Kholoud Alharbi, Ahmad Alenazy, Mohammed Alshahrani, Laila Perlas Asonto, Kathrina Libunao-de Loyola, Ali Al Bshabshe, Abdulmoniem Albahar, Ali Alamri, Abdulsalam Al Aithan, Shahinaz Bashir, Mohammed Almaani, Hani Lababidi, Husain Abdulmuthalib, Pendo Ntinika, Rachelle Pangilinan, Imran Khalid, Abdulaziz Jadkareem, Eman Bawazeer, Sawsan Bassi, Hassan Hawa, Khalid Maghrabi, Mohammad Hijazi, Musaab Abdelhai, Ellen Joy Pagunsan, Marketa Vinklerova, Sangeeta Mehta, Sumesh Shah, Erik Tamberg, Karen Burns, Orla Smith, Marlene Santos, Gyan Sandhu, Jennifer Hodder, Kurtis Salway, Michael Jacka, Lorena McCoshen, Nadia Baig, Atul Gaur, Katrina Ellis, Mary White, Rebecca Gregory, Rob Cameron, Simon Finfer, Anne O'Connor, Elizabeth Yarad, Frances Bass, Naomi Hammond, Hergen Buscher, Claire Reynolds, Karlee McCann, Zia Arshad, Sachin Kumar Srivastava, Avinash Singh, Yatin Mehta, Joby George, Chitra Mehta, Ashish Kumar

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.

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

Conflict of interest statement

Ethics approval and consent to participate

The study protocol as well as the informed consent have been approved by the Institutional Review Board of King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh and the respective Institutional Review Boards of all the other centers.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) flow chart for the PREVENT trial
Fig. 2
Fig. 2
Schedule of enrollment, intervention and assessment for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial

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