Plain English Summary
Background and study aims
Despite improvement in the prevention of thrombosis (thromboprophylaxis), venous thromboembolism (VTE) remains a common problem in critically ill patients. 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 intermittent pneumatic compression (IPC) to the legs in addition to the use of low-dose blood thinners (also called heparin thromboprophylaxis) provides an additional protection when compared to the use of blood thinners alone.
Who can participate?
Patients who are admitted to the intensive care unit are receiving low-dose blood thinners to prevent clots are candidate for this study.
What does the study involve?
Patients will be randomly allocated to one of two groups: all will receive blood thinners but some will additionally receive the leg compression.
What are the possible benefits and risks of participating?
The additional use of leg compression may provide protection from clots. The main side effect is possible skin abrasions but this is usually mild.
Where is the study run from?
The study will be conducted in several hospitals in Saudi Arabia, Canada, USA, India, and possibly other countries.
When is the study starting and how long is it expected to run for?
The study is planned to start in December 2013 and to continue for 4 years.
Who is funding the study?
King Abdullah International Medical Research Center (KAIMRC), Riyadh, Saudi Arabia.
Who is the main contact?
Each hospital will have a contact person but the main contact will be Dr Yaseen Arabi, firstname.lastname@example.org.
Prophylaxis of thromboembolism in critically ill patients using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone: a multicenter randomized controlled trial
Patients having pharmaceutical and mechanical prophylaxis will have better outcomes than patients having pharmaceutical prophylaxis alone.
Ethics Board: National Guard Health Affairs Institutional Review Board, Ref # IRBC/149/13, 18/06/2013
Randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Intensive care unit, critically ill patients, VTE prophylaxis
Intermittent pneumatic compression combined with pharmacologic prophylaxis compared to pharmacologic prophylaxis.
Patients will be randomized into one of the two intervention arms:
1. Treatment group: IPC and pharmacological thromboprophylaxis
2. Control group: pharmacological thromboprophylaxis alone
The study interventions will continue for the duration of the ICU stay or up to 30 days in ICU. Upon discharge from the ICU or 30 days in ICU, thromboprophylaxis will be at the discretion of treating team.
Patients will be followed daily until discharge from ICU or 30 days.
Primary outcome measures
Incident proximal leg deep vein thrombosis (DVT) will be followed up to 30 days
Secondary outcome measures
1. Pulmonary Embolism: will be followed up to ICU discharge or day 30
2. ICU Mortality. Death in ICU during the same ICU admission
3. 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). 30-day Mortality: Death before or at day 30 of enrollment. 90-day Mortalit: Death before or at day 90 of enrollment
1. ICU Length of Stay: Number of calendar days between admission and discharge from ICU
2. Duration of Mechanical Ventilation: Number of calendar days between start and end of mechanical ventilation
Overall trial start date
Overall trial end date
Participant inclusion criteria
All patients (male + female) admitted to ICU will be screened for eligibility
1. Medical-Surgical ICU patients >14 years old
2. Weight > 45 kg
3. Expected ICU LOS> 72 hours
4. Eligible for pharmacologic thromboprophylaxis with UFH and LMWH
Target number of participants
Participant exclusion criteria
1. Patient on IPC for > 24 hours in this current ICU admission
2. Patient on pharmacologic prophylaxis with medications other than UFH or LMWH
3. Inability or contraindication to applying IPC to both legs:
3.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs at the site of IPC placement
3.2. Acute ischemia in the lower extremities
3.3. Amputated foot or leg on one or two sides
3.4. Compartment Syndrome
3.5. Severe peripheral arterial disease
3.6. Vein ligation, gangrene, recent vein grafts, and draining incisions
3.7. Evidence of bone fracture in lower extremities
4. The need for therapeutic anticoagulation
6. Limitation of life support, life expectancy < 7 days or palliative care
7. Allergy to the sleeves material
Recruitment start date
Recruitment end date
Countries of recruitment
Canada, India, Saudi Arabia, United States of America
Trial participating centre
King Saud Bin Abdulaziz University for Health Sciences
King Abdullah International Medical Research Center (KAIMRC) (Saudi Arabia)
PO Box 22490
+966 (0)11 8011111 x43878/x14506
King Abdullah International Medical Research Center (KAIMRC), Riyadh, Saudi Arabia
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27488380