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 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, yaseenarabi@yahoo.com.
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT02040103
Protocol/serial number
RC 12/045
Study information
Scientific title
Prophylaxis of thromboembolism in critically ill patients using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone: a multicenter randomized controlled trial
Acronym
PREVENT
Study hypothesis
Patients having pharmaceutical and mechanical prophylaxis will have better outcomes than patients having pharmaceutical prophylaxis alone.
Ethics approval(s)
Ethics Board: National Guard Health Affairs Institutional Review Board, Ref # IRBC/149/13, 18/06/2013
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Intensive care unit, critically ill patients, VTE prophylaxis
Intervention
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.
Intervention type
Mixed
Primary outcome measure
Primary outcome measure as of 04/11/2017:
Incidence of proximal leg deep vein thrombosis (DVT) will be followed up to 28 days post randomization.
Original primary outcome measure:
Incident proximal leg deep vein thrombosis (DVT) will be followed up to 30 days
Secondary outcome measures
Secondary and tertiary outcome measure as of 04/11/2017:
Secondary outcomes:
1. Pulmonary Embolism: will be followed up to ICU discharge or day 28
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 Mortality: Death before or at day 90 of enrollment
Tertiary outcomes:
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
Original secondary and tertiary outcome measures:
Secondary outcomes:
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
Tertiary outcomes:
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 study start date
01/12/2013
Overall study end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
2000
Total final enrolment
2003
Participant exclusion criteria
Exclusion criteria as of 04/04/2017:
1. Patient treated with IPC for > 24 hours in this current ICU admission.
2. Patient in the ICU> 48 hours.
3. Patient treated with pharmacologic VTE prophylaxis with medications other than UFH or LMWH.
4. Inability or contraindication to applying IPC to both legs or to obtain adequate ultrasound on the lower extremities
4.1. Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs, large dressings at the site of IPC placement or in the thighs that prevent adequate ultrasounds
4.2. Acute ischemia in the lower extremities
4.3. Amputated foot or leg on one or two sides
4.4. Compartment Syndrome
4.5. Severe peripheral arterial disease
4.6. Vein ligation, gangrene, recent vein grafts, and draining incisions
4.7. Evidence of bone fracture in lower extremities
4.8. Arterial lines in the dorsalis pedis artery
5. Therapeutic dose of anticoagulation with UFH or LMWH
6. Pregnancy
7. Limitation of life support, life expectancy < 7 days or palliative care
8. Allergy to the sleeves material
9. Patients with Inferior Vena Cava (IVC) Filter
Eligible Non-Randomized Criteria
1. Patient or substitute decision maker declines consent but agrees to minimal data set collection
2. Unable to get consent within 48 hours of ICU admission
3. ICU physician or other treating clinician declines consent
4. Co-enrollment in trials with biologic interaction
Original 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
5. Pregnancy
6. Limitation of life support, life expectancy < 7 days or palliative care
7. Allergy to the sleeves material
Recruitment start date
14/07/2014
Recruitment end date
13/08/2018
Locations
Countries of recruitment
Australia, Brazil, Canada, India, Saudi Arabia
Study participating centre
King Abdulaziz Medical City
Ministry of National Guard Health Affairs (MNGHA)
Prince Mutib bin Abdullah Street
Riyadh
11426
Saudi Arabia
Study participating centre
Royal North Shore Hospital
Reserve Road
St Leonards
NSW 2065
Australia
Study participating centre
Saint Michael’s Hospital
30 Bond Sreet
Toronto
M5B 1W8
Canada
Study participating centre
Medanta, The Medicity
Sector 38
Gurugram
Haryana
122001
India
Study participating centre
Hospital do Coracao
R. Des. Eliseu Guilherme
147 - Paraíso
São Paulo
04004-030
Brazil
Sponsor information
Organisation
King Abdullah International Medical Research Center
Sponsor details
Ministry of National Guard Health Affairs (MNGHA)
Prince Muteb bin Abdullah Street
Riyadh
11426
Saudi Arabia
+966 (0)11 429 4502
kaimrc@ngha.med.sa
Sponsor type
Hospital/treatment centre
Website
ROR
Organisation
King Abdulaziz City for Science and Technology
Sponsor details
King Abdullah Road (West)
Riyadh
12371
Saudi Arabia
+966 (0)11 429 4502
gdrgp@kacst.edu.sa
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
King Abdullah International Medical Research Center
Alternative name(s)
KAIMRC
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Saudi Arabia
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
31/12/2019
Individual participant data (IPD) sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date.
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 03/08/2016 | Yes | No | |
| Results article | results | 04/04/2019 | Yes | No | |
| Results article | sub-study results | 01/04/2020 | 26/02/2020 | Yes | No |
| Results article | Secondary analysis | 20/05/2022 | 23/05/2022 | Yes | No |
| Other publications | Post hoc analysis | 03/03/2023 | 06/03/2023 | Yes | No |