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

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).

journal_name

Trials

journal_title

Trials

authors

Arabi YM,Alsolamy S,Al-Dawood A,Al-Omari A,Al-Hameed F,Burns KE,Almaani M,Lababidi H,Al Bshabshe A,Mehta S,Al-Aithan AM,Mandourah Y,Almekhlafi G,Finfer S,Abdukahil SA,Afesh LY,Dbsawy M,Sadat M

doi

10.1186/s13063-016-1520-0

subject

Has Abstract

pub_date

2016-08-03 00:00:00

pages

390

issue

1

issn

1745-6215

pii

10.1186/s13063-016-1520-0

journal_volume

17

pub_type

杂志文章,多中心研究,随机对照试验

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