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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial

Authors: Yaseen M Arabi, Sami Alsolamy, Abdulaziz Al-Dawood, Awad Al-Omari, Fahad Al-Hameed, Karen E. A. Burns, Mohammed Almaani, Hani Lababidi, Ali Al Bshabshe, Sangeeta Mehta, Abdulsalam M. Al-Aithan, Yasser Mandourah, Ghaleb Almekhlafi, Simon Finfer, Sheryl Ann I. Abdukahil, Lara Y. Afesh, Maamoun Dbsawy, Musharaf Sadat

Published in: Trials | Issue 1/2016

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Abstract

Background

Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis alone in critically ill patients reduces the risk of VTE.

Methods/Design

The PREVENT trial is a multicenter randomized controlled trial, which will recruit 2000 critically ill patients from over 20 hospitals in three countries. The primary outcome is the incidence of proximal lower extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the scans are blinded to intervention allocation, whereas the patients and caregivers are unblinded. The trial has 80 % power to detect a 3 % absolute risk reduction in proximal DVT from 7 to 4 %.

Discussion

The first patient was enrolled in July 2014. As of May 2015, a total of 650 patients have been enrolled from 13 centers in Saudi Arabia, Canada and Australia. The first interim analysis is anticipated in July 2016. We expect to complete recruitment by 2018.

Trial registration

Clinicaltrials.gov: NCT02040103 (registered on 3 November 2013).
Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).
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Metadata
Title
Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial
Authors
Yaseen M Arabi
Sami Alsolamy
Abdulaziz Al-Dawood
Awad Al-Omari
Fahad Al-Hameed
Karen E. A. Burns
Mohammed Almaani
Hani Lababidi
Ali Al Bshabshe
Sangeeta Mehta
Abdulsalam M. Al-Aithan
Yasser Mandourah
Ghaleb Almekhlafi
Simon Finfer
Sheryl Ann I. Abdukahil
Lara Y. Afesh
Maamoun Dbsawy
Musharaf Sadat
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1520-0

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