Pneumatic Compression for Preventing Venous Thromboembolism (PREVENT)

King Abdullah International Medical Research Center

Status

Completed

Conditions

Deep Venous Thrombosis

Treatments

Device: pneumatic compression

Study type

Interventional

Funder types

Other

Identifiers

NCT02040103

RC12-045

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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