Pneumatic Compression for Preventing Venous Thromboembolism (PREVENT)
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|ClinicalTrials.gov Identifier: NCT02040103|
Recruitment Status : Completed
First Posted : January 20, 2014
Last Update Posted : December 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Deep Venous Thrombosis||Device: pneumatic compression||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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
- 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.
- 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.
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
|Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs|
|Riyadh, Saudi Arabia, 11426|
|Principal Investigator:||Yaseen Arabi, MD||King Abdullah International Medical Research Center|