PREVENT: Pneumatic Compression for Preventing Venous Thromboembolism

Sponsor

King Abdullah International Medical Research Center (Other)

Overall Status

Completed

CT.gov ID

NCT02040103

Collaborator

King Abdulaziz Medical City, Jeddah (Other), King Abdulaziz Hospital, Al Ahsa (Other), Unity Health Toronto (Other), King Fahad Medical City (Other), Assir Central Hospital (Other), Royal North Shore Hospital (Other), Mount Sinai Hospital, Canada (Other), Prince Sultan Military Medical City (Other), King Faisal Specialist Hospital & Research Center, Jeddah (Other), Gosford Hospital, Australia (Other), St Vincent's Hospital - Sydney, Australia (Other), Medanta, The Medicity, India (Other), King Fahad Hospital of the University, Al Khobar (Other), King Faisal Specialist Hospital & Research Center, Riyadh (Other), King George's Medical University, India (Other)

2,000

Enrollment

Location

Arms

51.9

Actual Duration (Months)

38.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Deep Venous Thrombosis	Device: pneumatic compression	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 16, 2014

Actual Primary Completion Date :

Nov 13, 2018

Actual Study Completion Date :

Nov 13, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

ICU Length of stay and duration 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.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA

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

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.
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