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

• Published in: Current controlled trials in cardiovascular medicine Vol. 19; no. 1; p. 182
• Main Authors: Arabi, Yaseen, Al-Hameed, Fahad, Burns, Karen E A, Mehta, Sangeeta, Alsolamy, Sami, Almaani, Mohammed, Mandourah, Yasser, Almekhlafi, Ghaleb A, Al Bshabshe, Ali, Finfer, Simon, Alshahrani, Mohammed, Khalid, Imran, Mehta, Yatin, Gaur, Atul, Hawa, Hassan, Buscher, Hergen, Arshad, Zia, Lababidi, Hani, Al Aithan, Abdulsalam, Jose, Jesna, Abdukahil, Sheryl Ann I, Afesh, Lara Y, Dbsawy, Maamoun, Al-Dawood, Abdulaziz
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 15.03.2018; BioMed Central; BMC
• Subjects: Adjunct mechanical and pharmacologic DVT prophylaxis; Anticoagulants; Care and treatment; CAT scans; Catheters; Clinical trials; Compression therapy; Critically-ill patients; Data Interpretation, Statistical; Deep vein thrombosis; Diagnosis; Dosage and administration; Enrollments; Fractures; Humans; Intermittent pneumatic compression; Intermittent Pneumatic Compression Devices; Intervention; Multicenter Studies as Topic; Patient outcomes; Patients; Proteins; Pulmonary embolism; Pulmonary embolisms; Randomized Controlled Trials as Topic; Renal replacement therapy; Skin cancer; Statistical analysis; Study Protocol; Thromboembolism; Trauma; Treatment Outcome; Ultrasonic imaging; Venous Thromboembolism - prevention & control; Adjunct mechanical and pharmacologic DVT prophylaxis; Pulmonary embolism; Deep vein thrombosis; Critically-ill patients; Intermittent pneumatic compression
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-018-2534-6

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. 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%. 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. ClinicalTrials.gov , ID: NCT02040103 . Registered on 3 November 2013; Current controlled trials, ID: ISRCTN44653506 . Registered on 30 October 2013.