TY - JOUR
AU - Finfer Simon
AU - Arabi Yaseen
AU - Mehta Sangeeta
AU - Burns Karen
AU - Alshahrani Mohammed
AU - Al-Hameed Fahad
AU - Alsolamy Sami
AU - Almaani Mohammed
AU - Mandourah Yasser
AU - Almekhlafi Ghaleb
AU - Bshabshe Ali
AU - Khalid Imran
AU - Mehta Yatin
AU - Gaur Atul
AU - Hawa Hassan
AU - Buscher Hergen
AU - Arshad Zia
AU - Lababidi Hani
AU - Aithan Abdulsalam
AU - Jose Jesna
AU - Abdukahil Sheryl
AU - Afesh Lara
AU - Dbsawy Maamoun
AU - Al-Dawood Abdulaziz
AU - PREVENT trial Group
AB - <p><b>BACKGROUND: </b>The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults.</p><p><b>METHODS/DESIGN: </b>In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%.</p><p><b>DISCUSSION: </b>Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data.</p><p><b>TRIAL REGISTRATION: </b>ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.</p>
BT - Trials
C1 - https://www.ncbi.nlm.nih.gov/pubmed/29544550?dopt=Abstract
DO - 10.1186/s13063-018-2534-6
IS - 1
J2 - Trials
LA - eng
N2 - <p><b>BACKGROUND: </b>The Pneumatic CompREssion for Preventing VENous Thromboembolism (PREVENT) trial evaluates the effect of adjunctive intermittent pneumatic compression (IPC) with pharmacologic thromboprophylaxis compared to pharmacologic thromboprophylaxis alone on venous thromboembolism (VTE) in critically ill adults.</p><p><b>METHODS/DESIGN: </b>In this multicenter randomized trial, critically ill patients receiving pharmacologic thromboprophylaxis will be randomized to an IPC or a no IPC (control) group. The primary outcome is "incident" proximal lower-extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the lower-extremity ultrasonography will be blinded to intervention allocation, whereas the patients and treating team will be unblinded. The trial has 80% power to detect a 3% absolute risk reduction in the rate of proximal DVT from 7% to 4%.</p><p><b>DISCUSSION: </b>Consistent with international guidelines, we have developed a detailed plan to guide the analysis of the PREVENT trial. This plan specifies the statistical methods for the evaluation of primary and secondary outcomes, and defines covariates for adjusted analyses a priori. Application of this statistical analysis plan to the PREVENT trial will facilitate unbiased analyses of clinical data.</p><p><b>TRIAL REGISTRATION: </b>ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.</p>
PY - 2018
EP - 182
T2 - Trials
TI - Statistical analysis plan for the Pneumatic CompREssion for PreVENting Venous Thromboembolism (PREVENT) trial: a study protocol for a randomized controlled trial.
VL - 19
SN - 1745-6215
ER -