Pneumatic Compression for Preventing Venous Thromboembolism (PREVENT)

Prophylaxis of Thromboembolism in Critically Ill Patients Using Combined Intermittent Pneumatic Compression(IPC) and Pharmacologic Prophylaxis Versus Pharmacologic Prophylaxis Alone: A Multicenter Randomized Controlled Trial

Patients admitted to the intensive care unit are at high risk of developing clots in the veins of the lower extremities. The objective of this study is to examine whether the use of a device that provides intermittent compression to the legs in addition to the use of low-dose blood thinners, provides an additional protection when compared to the use of blood thinners alone. Patients who are admitted to the intensive care unit are receiving low-dose blood thinners to prevent clots are candidates for this study. Patients who are enrolled will continue to receive blood thinners but some will additionally receive the leg compression. The additional use of leg compression may provide protection from clots. The main side effect is possible skin abrasions but this is usually mild. The study is sponsored by King Abdullah International Medical Research Center(KAIMRC) and King Abdulaziz City for Science and Technology(KACST) and will be conducted in several hospitals in Saudi Arabia, Canada, Australia, Brazil and possibly other countries. The study started July 2014 and is to continue for 4 years.

Study Overview

• Status: Completed
• Conditions: Deep Venous Thrombosis
• Intervention / Treatment: Device: pneumatic compression

Detailed Description

There is no randomized controlled trial examining effect of the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis (UFH, LMWH) alone in critically ill patients for VTE prevention.

• Study Type: Interventional
• Enrollment (Actual): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11426
    • Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

INCLUSION CRITERIA

A. Medical-Surgical ICU patients >14 years old at participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years) B. Weight > 45kg C. Expected ICU LOS> 72hrs D. Eligible for pharmacologic thromboprophylaxis with UFH and LMWH.

EXCLUSION CRITERIA

A. Patient treated with IPC for > 24 hours in this current ICU admission. B. Patient in the ICU> 48 hours. C. Patient treated with pharmacologic VTE prophylaxis with medications other than UFH or LMWH.

D. Inability or contraindication to applying IPC to both legs i.Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs at the site of IPC placement ii. Acute ischemia in the lower extremities iii. Amputated foot or leg on one or two sides iv. Compartment Syndrome v. Severe peripheral arterial disease vi. Vein ligation, gangrene, recent vein grafts, and draining incisions vii. Evidence of bone fracture in lower extremities E. Therapeutic dose of anticoagulation with UFH or LMWH F. Pregnancy G. Limitation of life support, life expectancy < 7 days or palliative care H. Allergy to the sleeves material I. Patients with Inferior Vena Cava (IVC) Filter

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intermittent Pneumatic Compression(IPC); The intervention group will be receiving Intermittent Pneumatic Compression(IPC)	Device: pneumatic compression; All IPC devices intended for DVT prophylaxis are acceptable in the study. Sequential devices (cuffs have several chambers) are preferred, but non-sequential (cuffs have single chambers) are acceptable.
No Intervention: No Intermittent Pneumatic Compression; patients will not receive Intermittent Pneumatic Compression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound	The primary outcome is incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge or day 28 post randomization	28 days from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary Embolism	Pulmonary Embolism: will be followed up to ICU discharge or day 28 post randomization. ICU Mortality. Death in ICU during the same ICU admission. Hospital Mortality. Death in the hospital (in ICU or on ward) during the same hospital admission. (Hospital mortality will be censored at 1 year from the date of enrollment). 28-day Mortality: Death before or at day 28 of enrollment. 90-day Mortality: Death before or at day 90 of enrollment.	from the time of randomization to 90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICU Length of stay and duration of mechanical ventilation	ICU Length of stay: Number of calendar days between admission and discharge from ICU. Duration of mechanical ventilation: Number of calendar days between start and end of mechanical ventilation.	Number of days in ICU with an average expected duration of 10 days and number of days of mechanical ventillation with an expected average duration of 8 days.

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Collaborators: Unity Health Toronto; Mount Sinai Hospital, Canada; King Fahad Medical City; Royal North Shore Hospital; Medanta, The Medicity, India; King Abdulaziz Medical City, Jeddah; King Abdulaziz Hospital, Al Ahsa; Assir Central Hospital; Prince Sultan Military Medical City; King Faisal Specialist Hospital & Research Center, Jeddah; Gosford Hospital, Australia; St Vincent's Hospital - Sydney, Australia; King Fahad Hospital of the University, Al Khobar; King Faisal Specialist Hospital & Research Center, Riyadh; King George's Medical University, India
• Investigators: Principal Investigator: Yaseen Arabi, MD, King Abdullah International Medical Research Center

Publications and helpful links

General Publications

• Al-Dorzi HM, Al-Dawood A, Al-Hameed FM, Burns KEA, Mehta S, Jose J, Alsolamy S, Abdukahil SAI, Afesh LY, Alshahrani MS, Mandourah Y, Almekhlafi GA, Almaani M, Al Bshabshe A, Finfer S, Arshad Z, Khalid I, Mehta Y, Gaur A, Hawa H, Buscher H, Lababidi H, Al Aithan A, Arabi YM. The effect of intermittent pneumatic compression on deep-vein thrombosis and ventilation-free days in critically ill patients with heart failure. Sci Rep. 2022 May 20;12(1):8519. doi: 10.1038/s41598-022-12336-9.
• Arabi YM, Burns KEA, Alsolamy SJ, Alshahrani MS, Al-Hameed FM, Arshad Z, Almaani M, Hawa H, Mandourah Y, Almekhlafi GA, Al Aithan A, Khalid I, Rifai J, Rasool G, Abdukahil SAI, Jose J, Afesh LY, Al-Dawood A; Saudi Critical Care Trials Group. Surveillance or no surveillance ultrasonography for deep vein thrombosis and outcomes of critically ill patients: a pre-planned sub-study of the PREVENT trial. Intensive Care Med. 2020 Apr;46(4):737-746. doi: 10.1007/s00134-019-05899-1. Epub 2020 Feb 24.
• Arabi YM, Al-Hameed F, Burns KEA, Mehta S, Alsolamy SJ, Alshahrani MS, Mandourah Y, Almekhlafi GA, Almaani M, Al Bshabshe A, Finfer S, Arshad Z, Khalid I, Mehta Y, Gaur A, Hawa H, Buscher H, Lababidi H, Al Aithan A, Abdukahil SAI, Jose J, Afesh LY, Al-Dawood A; Saudi Critical Care Trials Group. Adjunctive Intermittent Pneumatic Compression for Venous Thromboprophylaxis. N Engl J Med. 2019 Apr 4;380(14):1305-1315. doi: 10.1056/NEJMoa1816150. Epub 2019 Feb 18.
• Arabi Y, Al-Hameed F, Burns KEA, Mehta S, Alsolamy S, Almaani M, Mandourah Y, Almekhlafi GA, Al Bshabshe A, Finfer S, Alshahrani M, Khalid I, Mehta Y, Gaur A, Hawa H, Buscher H, Arshad Z, Lababidi H, Al Aithan A, Jose J, Abdukahil SAI, Afesh LY, Dbsawy M, Al-Dawood A; PREVENT trial Group. Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial. Trials. 2018 Mar 15;19(1):182. doi: 10.1186/s13063-018-2534-6.
• 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. Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial. Trials. 2016 Aug 3;17(1):390. doi: 10.1186/s13063-016-1520-0. Erratum In: Trials. 2016;17(1):420.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2014
• Primary Completion (Actual): November 13, 2018
• Study Completion (Actual): November 13, 2018

Study Registration Dates

• First Submitted: November 3, 2013
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Actual): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Deep Vein Thrombosis; Intermittent Pneumatic Compression; Prophylaxis; Pulmonary Embolism; Pharmacologic DVT; Critically Ill Patients.
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Thromboembolism
• Other Study ID Numbers: RC12-045