Economic evaluation of the prophylaxis for thromboembolism in critical care trial (E-PROTECT): Study protocol for a randomized controlled trial

Robert A. Fowler*, Nicole Mittmann, William H. Geerts, Diane Heels-Ansdell, Michael K. Gould, Gordon Guyatt, Murray Krahn, Simon Finfer, Ruxandra Pinto, Brian Chan, Orges Ormanidhi, Yaseen Arabi, Ismael Qushmaq, Marcelo G. Rocha, Peter Dodek, Lauralyn McIntyre, Richard Hall, Niall D. Ferguson, Sangeeta Mehta, John C. MarshallChristopher James Doig, John Muscedere, Michael J. Jacka, James R. Klinger, Nicholas Vlahakis, Neil Orford, Ian Seppelt, Yoanna K. Skrobik, Sachin Sud, John F. Cade, Jamie Cooper, Deborah Cook, Canadian Critical Care Trials Group, Australia and New Zealand Intensive Care Society Clinical Trials Group

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    6 Citations (Scopus)

    Abstract

    Background: Venous thromboembolism (VTE) is a common complication of critical illness with important clinical consequences. The Prophylaxis for ThromboEmbolism in Critical Care Trial (PROTECT) is a multicenter, blinded, randomized controlled trial comparing the effectiveness of the two most common pharmocoprevention strategies, unfractionated heparin (UFH) and low molecular weight heparin (LMWH) dalteparin, in medical-surgical patients in the intensive care unit (ICU). E-PROTECT is a prospective and concurrent economic evaluation of the PROTECT trial. Methods/Design: The primary objective of E-PROTECT is to identify and quantify the total (direct and indirect, variable and fixed) costs associated with the management of critically ill patients participating in the PROTECT trial, and, to combine costs and outcome results to determine the incremental cost-effectiveness of LMWH versus UFH, from the acute healthcare system perspective, over a data-rich time horizon of ICU admission and hospital admission. We derive baseline characteristics and probabilities of in-ICU and in-hospital events from all enrolled patients. Total costs are derived from centers, proportional to the numbers of patients enrolled in each country. Direct costs include medication, physician and other personnel costs, diagnostic radiology and laboratory testing, operative and non-operative procedures, costs associated with bleeding, transfusions and treatment-related complications. Indirect costs include ICU and hospital ward overhead costs. Outcomes are the ratio of incremental costs per incremental effects of LMWH versus UFH during hospitalization; incremental cost to prevent a thrombosis at any site (primary outcome); incremental cost to prevent a pulmonary embolism, deep vein thrombosis, major bleeding event or episode of heparin-induced thrombocytopenia (secondary outcomes) and incremental cost per life-year gained (tertiary outcome). Pre-specified subgroups and sensitivity analyses will be performed and confidence intervals for the estimates of incremental cost-effectiveness will be obtained using bootstrapping. Discussion: This economic evaluation employs a prospective costing methodology concurrent with a randomized controlled blinded clinical trial, with a pre-specified analytic plan, outcome measures, subgroup and sensitivity analyses. This economic evaluation has received only peer-reviewed funding and funders will not play a role in the generation, analysis or decision to submit the manuscripts for publication.

    Original languageEnglish
    Article number502
    Pages (from-to)1-11
    Number of pages11
    JournalTrials
    Volume15
    Issue number1
    DOIs
    Publication statusPublished - 20 Dec 2014

    Bibliographical note

    Copyright the Author(s) 2014. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

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