Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial

Abstract

BackgroundVenous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis alone in critically ill patients reduces the risk of VTE.Methods/DesignThe PREVENT trial is a multicenter randomized controlled trial, which will recruit 2000 critically ill patients from over 20 hospitals in three countries. The primary outcome is the incidence of proximal lower extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the scans are blinded to intervention allocation, whereas the patients and caregivers are unblinded. The trial has 80 % power to detect a 3 % absolute risk reduction in proximal DVT from 7 to 4 %.DiscussionThe first patient was enrolled in July 2014. As of May 2015, a total of 650 patients have been enrolled from 13 centers in Saudi Arabia, Canada and Australia. The first interim analysis is anticipated in July 2016. We expect to complete recruitment by 2018.Trial registrationClinicaltrials.gov: NCT02040103 (registered on 3 November 2013).Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).

Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016

“…Combined pharmacologic prophylaxis and mechanical prophylaxis with intermittent pneumatic compression (IPC) and/or graduated compression stockings (GCS) is a potential option in critically ill patients with sepsis and septic shock. No high-quality studies of this approach in septic patients, or even critically ill patients in general, exist; however, further research is ongoing [523]. A Cochrane review [524] of 11 studies in surgical patients suggested that combined prophylaxis was more effective than either modality used alone.…”

Surveillance or no surveillance for deep venous thrombosis and outcomes of critically ill patients

“…The trial protocol and statistical analysis plan have been published previously. [ 9 , 10 ] The trial is registered at Clinicaltrials.gov: NCT02040103 and Current controlled trials: ISRCTN44653506. The PREVENT trial is being conducted in 19 sites in Saudi Arabia, Canada, Australia, and India.…”

Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial

“…1 ). Exclusion criteria have been detailed in the protocol manuscript [ 5 ]. To enhance the generalizability of our findings, we permit the use of a broad array of IPC devices from various manufacturers intended for DVT prophylaxis.…”

“…These outcomes test the secondary hypotheses that IPC reduces the extent of incident proximal lower-extremity DVT and reduces central-venous-catheter- and non-central-venous-catheter-related incident proximal lower-extremity DVT Unilateral incident proximal lower-extremity DVT Bilateral incident proximal lower-extremity DVT Number of veins with DVT. As per our protocol, the venous system is examined by documenting compressibility at the following six sites: common femoral, proximal superficial femoral, mid superficial femoral, distal superficial femoral, popliteal veins and trifurcation [ 5 ]. We will document the number of veins involved as a measure of DVT extent Complete occlusion (with one vein at least non-compressible) Incomplete occlusion (with all veins at least partially compressible) Central-venous-catheter-related incident proximal lower-extremity DVT as defined previously [ 5 ] Non-central-venous-catheter-related incident proximal lower-extremity DVT Secondary outcomes related to lower-extremity DVT other than incident proximal lower-extremity DVT Prevalent – proximal DVT.…”

“…The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial is a concealed, stratified, unblinded, international, multicenter randomized controlled trial (RCT) that examines the effectiveness of adjunct IPC use with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis (with unfractionated heparin (UFH) or low-molecular-weight heparin (LMWH)) alone on the incidence of proximal lower-extremity DVT in critically ill patients. The trial protocol has been published previously [ 5 ].…”