Condition category
Circulatory System
Date applied
22/07/2013
Date assigned
30/10/2013
Last edited
05/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer 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

Incident proximal leg deep vein thrombosis (DVT) will be followed up to 30 days

Secondary 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

01/12/2015

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

3726

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
5. Pregnancy
6. Limitation of life support, life expectancy < 7 days or palliative care
7. Allergy to the sleeves material

Recruitment start date

01/12/2013

Recruitment end date

01/12/2015

Locations

Countries of recruitment

Canada, India, Saudi Arabia, United States of America

Trial participating centre

King Saud Bin Abdulaziz University for Health Sciences
Riyadh
11426
Saudi Arabia

Sponsor information

Organisation

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

Sponsor details

PO Box 22490
Riyadh
11426
Saudi Arabia
+966 (0)11 8011111 x43878/x14506
research1@ngha.med.sa

Sponsor type

Hospital/treatment centre

Website

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

05/08/2016: Publication reference added.