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Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial

Authors: Toby Richards, Ben Clevenger, Jane Keidan, Tim Collier, Andrew A. Klein, Stefan D. Anker, John D. Kelly

Published in: Trials | Issue 1/2015

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Abstract

Background

Anaemia is common in patients undergoing major surgery. The current standard of care for patients with low haemoglobin in the peri-operative period is blood transfusion. The presence of preoperative anaemia is associated with an increased likelihood of the patient receiving peri-operative transfusion and worsened outcomes following surgery, more post-operative complications, delayed recovery and greater length of hospital stay. Intravenous iron, if applied in the preoperative setting, may correct anaemia by the time of surgery and reduce the need for blood transfusion and improve outcomes.

Methods/Design

PREVENTT is a phase III double-blind randomised controlled trial that will compare the use of intravenous ferric carboxymaltose (dose 1000 mg) with placebo 10–42 days before major open abdominal surgery in 500 patients with anaemia (haemoglobin < 120 g/L). The primary outcome measure will be the need for blood transfusion and secondary endpoints will include post-operative recovery, length of hospital stay, health care utilisation and cost analysis.

Trial registration

ISRCTN67322816 – registered 9 October 2012.
ClinicalTrials.gov identifier: NCT01692418.
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Metadata
Title
PREVENTT: preoperative intravenous iron to treat anaemia in major surgery: study protocol for a randomised controlled trial
Authors
Toby Richards
Ben Clevenger
Jane Keidan
Tim Collier
Andrew A. Klein
Stefan D. Anker
John D. Kelly
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0774-2

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