Pneumatic Compression for Preventing Venous Thromboembolism

N/ACompletedNCT02040103

King Abdullah International Medical Research Center2,000 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

2,000

Conditions

Deep Venous Thrombosis

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 28 days from randomization

Secondary Outcomes

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.

Time frame: from the time of randomization to 90 days