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

Overview of attention for article published in Trials, March 2018
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Title
Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial
Published in
Trials, March 2018
DOI 10.1186/s13063-018-2534-6
Pubmed ID
Authors

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

Abstract

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. 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%. 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. ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.

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Geographical breakdown

Country Count As %
Unknown 56 100%

Demographic breakdown

Readers by professional status Count As %
Researcher 8 14%
Other 7 13%
Student > Ph. D. Student 5 9%
Student > Bachelor 4 7%
Student > Postgraduate 4 7%
Other 11 20%
Unknown 17 30%
Readers by discipline Count As %
Medicine and Dentistry 23 41%
Nursing and Health Professions 7 13%
Pharmacology, Toxicology and Pharmaceutical Science 2 4%
Agricultural and Biological Sciences 1 2%
Psychology 1 2%
Other 3 5%
Unknown 19 34%