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Completed

NCT Number: NCT02040103

Pneumatic Compression for Preventing Venous Thromboembolism

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.

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Key information

Conditions

Deep Venous Thrombosis Cardiovascular Diseases Embolism Embolism and Thrombosis Lung Diseases Pulmonary Embolism Respiratory Tract Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs

Riyadh, 11426, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pneumatic compression

Device

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.

Primary outcomes

  1. Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound

    Time frame: 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 outcomes

  1. Pulmonary Embolism

    Time frame: 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 outcomes

  1. ICU Length of stay and duration of mechanical ventilation

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Collaborators

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

Registry information

Official study 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

Acronym: PREVENT

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2014
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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