Pneumatic Compression for Preventing Venous Thromboembolism

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.

Conditions

• Deep Venous Thrombosis

Interventions

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.

Sponsors & Collaborators

• King Abdulaziz Medical City, Jeddah

  collaborator UNKNOWN

• King Abdulaziz Hospital, Al Ahsa

  collaborator UNKNOWN

• Unity Health Toronto

  collaborator OTHER

• King Fahad Medical City

  collaborator OTHER_GOV

• Assir Central Hospital

  collaborator UNKNOWN

• Royal North Shore Hospital

  collaborator OTHER

• Mount Sinai Hospital, Canada

  collaborator OTHER

• Prince Sultan Military Medical City

  collaborator OTHER

• King Faisal Specialist Hospital & Research Center

  collaborator OTHER

• Gosford Hospital, Australia

  collaborator UNKNOWN

• St Vincent's Hospital - Sydney, Australia

  collaborator OTHER

• Medanta, The Medicity, India

  collaborator OTHER

• King Fahad Hospital of the University, Al Khobar

  collaborator UNKNOWN

• King George's Medical University, India

  collaborator UNKNOWN

• King Abdullah International Medical Research Center

  lead OTHER

Principal Investigators

• Yaseen Arabi, MD · King Abdullah International Medical Research Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-07-16

Primary Completion

2018-11-13

Completion

2018-11-13

Countries

• Saudi Arabia

Study Locations