Pneumatic Compression for Preventing Venous Thromboembolism

Not Applicable

Completed

• Conditions: Deep Venous Thrombosis
• Interventions: Device: pneumatic compression

• Registration Number: NCT02040103
• Lead Sponsor: King Abdullah International Medical Research Center

Brief Summary

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.

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 Timeline

• Study First Submitted: 2013-11-03
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Study Start: 2014-07-16
• Primary Completion: 2018-11-13
• Study Completion: 2018-11-13
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent Pneumatic Compression(IPC)	pneumatic compression	The intervention group will be receiving Intermittent Pneumatic Compression(IPC)

Primary Outcome Measures

Name	Time	Method
Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound	28 days from randomization	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

Secondary Outcome Measures

Name	Time	Method
Pulmonary Embolism	from the time of randomization to 90 days	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.

Trial Locations

Locations (1)

Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs; 🇸🇦 Riyadh, Saudi Arabia