ClinicalTrials.gov
ClinicalTrials.gov Menu

Pneumatic Compression for Preventing Venous Thromboembolism (PREVENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02040103
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
King Abdulaziz Medical City, Jeddah
King Abdulaziz Hospital, Al Ahsa
St. Michael's Hospital, Toronto
King Fahad Medical City
Assir Central Hospital
Royal North Shore Hospital
Mount Sinai Hospital, Canada
Prince Sultan Military Medical City
King Faisal Specialist Hospital & Research Center, Jeddah
Gosford Hospital, Australia
St Vincent's Hospital - Sydney, Australia
Medanta, The Medicity, India
King Fahad Hospital of the University, Al Khobar
King Faisal Specialist Hospital & Research Center, Riyadh
King George's Medical University, India
Information provided by (Responsible Party):
Dr Yaseen Arabi, King Abdulaziz Medical City

Brief 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.

Condition or disease Intervention/treatment Phase
Deep Venous Thrombosis Device: pneumatic compression Not Applicable

Detailed Description:
There is no randomized controlled trial examining effect of the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis (UFH, LMWH) alone in critically ill patients for VTE prevention.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prophylaxis of Thromboembolism in Critically Ill Patients Using Combined Intermittent Pneumatic Compression(IPC) and Pharmacologic Prophylaxis Versus Pharmacologic Prophylaxis Alone: A Multicenter Randomized Controlled Trial
Actual Study Start Date : July 16, 2014
Actual Primary Completion Date : November 13, 2018
Actual Study Completion Date : November 13, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intermittent Pneumatic Compression(IPC)
The intervention group will be receiving Intermittent Pneumatic Compression(IPC)
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.

No Intervention: No Intermittent Pneumatic Compression
patients will not receive Intermittent Pneumatic Compression



Primary Outcome Measures :
  1. Proximal deep vein thrombosis(DVT) diagnosed by compression ultrasound [ Time Frame: 28 days from randomization ]
    The primary outcome is incident proximal leg DVT, defined as detected 3 or more days post-randomization and up to ICU discharge or day 28 post randomization


Secondary Outcome Measures :
  1. Pulmonary Embolism [ Time Frame: from the time of randomization to 90 days ]

    Pulmonary Embolism: will be followed up to ICU discharge or day 28 post randomization.

    ICU Mortality. Death in ICU during the same ICU admission. 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).

    28-day Mortality: Death before or at day 28 of enrollment. 90-day Mortality: Death before or at day 90 of enrollment.



Other Outcome Measures:
  1. ICU Length of stay and duration of mechanical ventilation [ Time Frame: Number of days in ICU with an average expected duration of 10 days and number of days of mechanical ventillation with an expected average duration of 8 days. ]

    ICU Length of stay: Number of calendar days between admission and discharge from ICU.

    Duration of mechanical ventilation: Number of calendar days between start and end of mechanical ventilation.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

A. Medical-Surgical ICU patients >14 years old at participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years) B. Weight > 45kg C. Expected ICU LOS> 72hrs D. Eligible for pharmacologic thromboprophylaxis with UFH and LMWH.

EXCLUSION CRITERIA

A. Patient treated with IPC for > 24 hours in this current ICU admission. B. Patient in the ICU> 48 hours. C. Patient treated with pharmacologic VTE prophylaxis with medications other than UFH or LMWH.

D. Inability or contraindication to applying IPC to both legs i.Burns in the lower extremities, lacerations, active skin infection, & ischemic limb in the legs at the site of IPC placement ii. Acute ischemia in the lower extremities iii. Amputated foot or leg on one or two sides iv. Compartment Syndrome v. Severe peripheral arterial disease vi. Vein ligation, gangrene, recent vein grafts, and draining incisions vii. Evidence of bone fracture in lower extremities E. Therapeutic dose of anticoagulation with UFH or LMWH F. Pregnancy G. Limitation of life support, life expectancy < 7 days or palliative care H. Allergy to the sleeves material I. Patients with Inferior Vena Cava (IVC) Filter


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02040103


Locations
Saudi Arabia
Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, Saudi Arabia, 11426
Sponsors and Collaborators
King Abdullah International Medical Research Center
King Abdulaziz Medical City, Jeddah
King Abdulaziz Hospital, Al Ahsa
St. Michael's Hospital, Toronto
King Fahad Medical City
Assir Central Hospital
Royal North Shore Hospital
Mount Sinai Hospital, Canada
Prince Sultan Military Medical City
King Faisal Specialist Hospital & Research Center, Jeddah
Gosford Hospital, Australia
St Vincent's Hospital - Sydney, Australia
Medanta, The Medicity, India
King Fahad Hospital of the University, Al Khobar
King Faisal Specialist Hospital & Research Center, Riyadh
King George's Medical University, India
Investigators
Principal Investigator: Yaseen Arabi, MD King Abdullah International Medical Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Yaseen Arabi, Chairman, Intensive Care Department, King Abdulaziz Medical City
ClinicalTrials.gov Identifier: NCT02040103     History of Changes
Other Study ID Numbers: RC12-045
First Posted: January 20, 2014    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Keywords provided by Dr Yaseen Arabi, King Abdulaziz Medical City:
Deep Vein Thrombosis
Pulmonary Embolism
Intermittent Pneumatic Compression
Pharmacologic DVT
Prophylaxis
Critically Ill Patients.

Additional relevant MeSH terms:
Thrombosis
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases