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

重症监护试验中血栓栓塞预防的经济学评估(E-PROTECT):随机对照试验的研究方案

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作者: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 Me

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.

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.

Trial registration

Clinicaltrials.gov Identifier: NCT00182143 . Date of registration: 10 September 2005.

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