Condition category
Circulatory System
Date applied
22/07/2013
Date assigned
30/10/2013
Last edited
09/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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, yaseenarabi@yahoo.com.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Yaseen Arabi

ORCID ID

Contact details

King Saud Bin Abdulaziz University for Health Sciences
King Abdulaziz Medical City
ICU 1425
PO Box 22490
Riyadh
11426
Saudi Arabia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2013

Overall trial end date

30/08/2018

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

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

30/05/2018

Locations

Countries of recruitment

Australia, Brazil, Canada, India, Saudi Arabia

Trial participating centre

King Abdulaziz Medical City
Ministry of National Guard Health Affairs (MNGHA) Prince Mutib bin Abdullah Street
Riyadh
11426
Saudi Arabia

Trial participating centre

Royal North Shore Hospital
Reserve Road
St Leonards
NSW 2065
Australia

Trial participating centre

Saint Michael’s Hospital
30 Bond Sreet
Toronto
M5B 1W8
Canada

Trial participating centre

Medanta, The Medicity
Sector 38 Gurugram
Haryana
122001
India

Trial 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 (KAIMRC)

Sponsor details

Ministry of National Guard Health Affairs (MNGHA)
Prince Muteb bin Abdullah Street
Riyadh
11426
Saudi Arabia
+966 11 429 4502
kaimrc@ngha.med.sa

Sponsor type

Hospital/treatment centre

Website

www.kaimrc.med.sa

Organisation

King Abdulaziz City for Science and Technology

Sponsor details

King Abdullah Road (West)
Riyadh
12371
Saudi Arabia
+966 11 429 4502
gdrgp@kacst.edu.sa

Sponsor type

Research organisation

Website

www.kacst.edu.sa

Funders

Funder type

Research organisation

Funder name

King Abdullah International Medical Research Center (KAIMRC), Riyadh, Saudi Arabia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27488380

Publication citations

Additional files

Editorial Notes

09/01/2017: The following changes have been made to the record: 1. King Abdulaziz City for Science and Technology has been added as a co-sponsor 2. The lead sites from each country have been added as trial participating centres 3. The recruitment dates have been updated from 01/12/2013 - 01/12/2015 to 14/07/2014 - 30/05/2018 4. The target number of participants had been updated from 3726 to 2000 04/01/2017: The following changes have been made to the record: 1. The overall trial end date has been updated from 01/12/2015 to 30/08/2018 2. The outcome measures and exclusion criteria have been updated 3. Australia and Brazil have been added to the list of countries of recruitment 05/08/2016: Publication reference added.