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.
abstract: 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.
  
  
  
  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 %.
  
  
  
  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.
  
  
  
  Clinicaltrials.gov: NCT02040103 (registered on 3 November 2013). Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).
authors.affiliation: Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, ICU 1425, PO Box 22490, Riyadh, 11426, Kingdom of Saudi Arabia. arabi@ngha.med.sa.
authors.forename: Yaseen M
authors.identifier: 0000-0001-5735-6241
authors.initials: YM
authors.lastname: Arabi
authors.affiliation: Emergency Medicine and Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Sami
authors.initials: S
authors.lastname: Alsolamy
authors.affiliation: Intensive Care Department, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, ICU 1425, PO Box 22490, Riyadh, 11426, Kingdom of Saudi Arabia.
authors.forename: Abdulaziz
authors.initials: A
authors.lastname: Al-Dawood
authors.affiliation: Alfaisal University, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Awad
authors.initials: A
authors.lastname: Al-Omari
authors.affiliation: Intensive Care Department, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Jeddah, Kingdom of Saudi Arabia.
authors.forename: Fahad
authors.initials: F
authors.lastname: Al-Hameed
authors.affiliation: Interdepartmental Division of Critical Care Medicine, Li Ka Shing Knowledge Institute, St Michael's Hospital, Toronto, ON, Canada.
authors.forename: Karen E A
authors.initials: KE
authors.lastname: Burns
authors.affiliation: Department of Pulmonary and Critical Care Medicine, King Fahad Medical City, ᅟRiyadh, ᅟSaudi Arabia.|King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Mohammed
authors.initials: M
authors.lastname: Almaani
authors.affiliation: Department of Pulmonary and Critical Care Medicine, King Fahad Medical City, ᅟRiyadh, ᅟSaudi Arabia.
authors.forename: Hani
authors.initials: H
authors.lastname: Lababidi
authors.affiliation: Department of Critical Care Medicine, King Khalid University, Assir Central Hospital, Abha, Kingdom of Saudi Arabia.
authors.forename: Ali
authors.initials: A
authors.lastname: Al Bshabshe
authors.affiliation: Medical/Surgical ICU, University of Toronto, Mount Sinai Hospital, Toronto, ON, Canada.
authors.forename: Sangeeta
authors.initials: S
authors.lastname: Mehta
authors.affiliation: Intensive Care Department, King Abdulaziz Hospital, Al Ahsa, Kingdom of Saudi Arabia.
authors.forename: Abdulsalam M
authors.initials: AM
authors.lastname: Al-Aithan
authors.affiliation: Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Kingdom of Saudi Arabia.|International Extended Care Centers, ᅟJeddah, ᅟSaudi Arabia.
authors.forename: Yasser
authors.initials: Y
authors.lastname: Mandourah
authors.affiliation: Department of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Ghaleb
authors.initials: G
authors.lastname: Almekhlafi
authors.affiliation: Intensive Care Royal North Shore Hospital of Sydney and Sydney Adventist Hospital, The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
authors.forename: Simon
authors.initials: S
authors.lastname: Finfer
authors.affiliation: Intensive Care Department, King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Sheryl Ann I
authors.initials: SA
authors.lastname: Abdukahil
authors.affiliation: King Abdullah International Medical Research Center, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Lara Y
authors.initials: LY
authors.lastname: Afesh
authors.affiliation: Intensive Care Department, King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Maamoun
authors.initials: M
authors.lastname: Dbsawy
authors.affiliation: Intensive Care Department, King Abdulaziz Medical City, Riyadh, Kingdom of Saudi Arabia.
authors.forename: Musharaf
authors.initials: M
authors.lastname: Sadat
mesh_terms: D001315:Australia; D002170:Canada; D002985:Clinical Protocols; D016638:Critical Illness; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006493:Heparin / Q000009:adverse effects / Q000627:therapeutic use*; D006495:Heparin, Low-Molecular-Weight / Q000627:therapeutic use; D006801:Humans; D048228:Intermittent Pneumatic Compression Devices / Q000009:adverse effects; D035002:Lower Extremity / Q000098:blood supply*; D011655:Pulmonary Embolism / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D012107:Research Design; D012307:Risk Factors; D012529:Saudi Arabia; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D020246:Venous Thrombosis / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*
chemical_list: D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; D006493:Heparin
keywords: Adjunct mechanical and pharmacologic DVT prophylaxis; Critically ill patients; Deep vein thrombosis; Intermittent pneumatic compression; Pulmonary embolism