{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T01:40:06Z","timestamp":1778895606957,"version":"3.51.4"},"reference-count":36,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2023,3,21]],"date-time":"2023-03-21T00:00:00Z","timestamp":1679356800000},"content-version":"unspecified","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002028","name":"Collins Medical Trust","doi-asserted-by":"publisher","award":["No award\/grant number"],"award-info":[{"award-number":["No award\/grant number"]}],"id":[{"id":"10.13039\/100002028","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006668","name":"Oregon Health and Science University","doi-asserted-by":"publisher","award":["MRF Early Clinical Investigator (no grant number)"],"award-info":[{"award-number":["MRF Early Clinical Investigator (no grant number)"]}],"id":[{"id":"10.13039\/100006668","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013769","name":"Orthopaedic Trauma Association","doi-asserted-by":"publisher","award":["Resident Research Grant #7329"],"award-info":[{"award-number":["Resident Research Grant #7329"]}],"id":[{"id":"10.13039\/100013769","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,3,6]]},"published-print":{"date-parts":[[2023,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Orthopaedic trauma and fracture care commonly cause perioperative anaemia and associated functional iron deficiency due to a systemic inflammatory state. Modern, strict transfusion thresholds leave many patients anaemic; managing this perioperative anaemia is an opportunity to impact outcomes in orthopaedic trauma surgery. The primary outcome of this pilot study is feasibility for a large randomised controlled trial (RCT) to evaluate intravenous iron therapy (IVIT) to improve patient well-being following orthopaedic injury. Measurements will include rate of participant enrolment, screening failure, follow-up, missing data, adverse events and protocol deviation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This single-centre, pilot, double-blind RCT investigates the use of IVIT for acute blood loss anaemia in traumatically injured orthopaedic patients. Patients are randomised to receive either a single dose infusion of low-molecular weight iron dextran (1000\u2009mg) or placebo (normal saline) postoperatively during their hospital stay for trauma management. Eligible subjects include adult patients admitted for lower extremity or pelvis operative fracture care with a haemoglobin of 7\u201311\u2009g\/dL within 7\u2009days postoperatively during inpatient care. Exclusion criteria include history of intolerance to intravenous iron supplementation, active haemorrhage requiring ongoing blood product resuscitation, multiple planned procedures, pre-existing haematologic disorders or chronic inflammatory states, iron overload on screening or vulnerable populations. We follow patients for 3\u2009months to measure the effect of iron supplementation on clinical outcomes (resolution of anaemia and functional iron deficiency), patient-reported outcomes (fatigue, physical function, depression and quality of life) and translational measures of immune cell function.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study has ethics approval (Oregon Health &amp; Science University Institutional Review Board, STUDY00022441). We will disseminate the findings through peer-reviewed publications and conference presentations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT05292001\">NCT05292001<\/jats:ext-link>\n                      ; ClinicalTrials.gov.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-069070","type":"journal-article","created":{"date-parts":[[2023,5,3]],"date-time":"2023-05-03T07:02:53Z","timestamp":1683097373000},"page":"e069070","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Role of single-dose intravenous iron therapy for the treatment of anaemia after orthopaedic trauma: protocol for a pilot randomised controlled trial"],"prefix":"10.1136","volume":"13","clinical-trial-number":[{"clinical-trial-number":"nct05292001","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4079-7563","authenticated-orcid":false,"given":"Danielle F","family":"Peterson","sequence":"first","affiliation":[{"name":"Orthopaedics & Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9392-8064","authenticated-orcid":false,"given":"Natasha S","family":"McKibben","sequence":"additional","affiliation":[{"name":"Orthopaedics & Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine E","family":"Hutchison","sequence":"additional","affiliation":[{"name":"Orthopaedics & Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karalynn","family":"Lancaster","sequence":"additional","affiliation":[{"name":"Orthopaedics & Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chih Jen","family":"Yang","sequence":"additional","affiliation":[{"name":"Biomedical Engineering, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Graham J","family":"Dekeyser","sequence":"additional","affiliation":[{"name":"Orthopaedics & Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Darin M","family":"Friess","sequence":"additional","affiliation":[{"name":"Orthopaedics & Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin A","family":"Schreiber","sequence":"additional","affiliation":[{"name":"Critical Care and Acute Care Surgery, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nick J","family":"Willett","sequence":"additional","affiliation":[{"name":"Bioengineering, University of Oregon, Eugene, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph J","family":"Shatzel","sequence":"additional","affiliation":[{"name":"Biomedical Engineering, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph E","family":"Aslan","sequence":"additional","affiliation":[{"name":"Biomedical Engineering, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1768-1001","authenticated-orcid":false,"given":"Zachary M","family":"Working","sequence":"additional","affiliation":[{"name":"Orthopaedics & Rehabilitation, Oregon Health & Science University, Portland, Oregon, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2023,3,21]]},"reference":[{"key":"2025121221482059000_13.3.e069070.1","doi-asserted-by":"crossref","first-page":"e1077","DOI":"10.5435\/JAAOS-D-18-00810","article-title":"Treating preoperative anemia to improve patient outcomes after orthopaedic surgery","volume":"27","author":"Shanbhag","year":"2019","journal-title":"J Am Acad Orthop Surg"},{"key":"2025121221482059000_13.3.e069070.2","doi-asserted-by":"publisher","DOI":"10.1097\/ALN.0b013e3181e08e97"},{"key":"2025121221482059000_13.3.e069070.3","doi-asserted-by":"crossref","first-page":"219","DOI":"10.1111\/vox.12477","article-title":"Single-dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: a randomized controlled trial","volume":"112","author":"Holm","year":"2017","journal-title":"Vox Sang"},{"key":"2025121221482059000_13.3.e069070.4","doi-asserted-by":"crossref","first-page":"285","DOI":"10.2147\/PROM.S169653","article-title":"Health-related quality of life in patients with iron deficiency anemia: impact of treatment with intravenous iron","volume":"9","author":"Strauss","year":"2018","journal-title":"Patient Relat Outcome Meas"},{"key":"2025121221482059000_13.3.e069070.5","doi-asserted-by":"crossref","first-page":"633","DOI":"10.1111\/ejh.13870","article-title":"The incidence, complications, and treatment of iron deficiency in pregnancy","volume":"109","author":"Benson","year":"2022","journal-title":"Eur J Haematol"},{"key":"2025121221482059000_13.3.e069070.6","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0215427","article-title":"Efficacy of perioperative intravenous iron therapy for transfusion in orthopedic surgery: a systematic review and meta-analysis","volume":"14","author":"Shin","year":"2019","journal-title":"PLOS ONE"},{"key":"2025121221482059000_13.3.e069070.7","doi-asserted-by":"crossref","first-page":"1715","DOI":"10.1007\/s00134-016-4465-6","article-title":"Intravenous iron or placebo for anaemia in intensive care: the IRONMAN multicentre randomized blinded trial: A randomized trial of IV iron in critical illness","volume":"42","author":"Litton","year":"2016","journal-title":"Intensive Care Med"},{"key":"2025121221482059000_13.3.e069070.8","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2010.02769.x"},{"key":"2025121221482059000_13.3.e069070.9","doi-asserted-by":"crossref","first-page":"2797","DOI":"10.1080\/14767058.2018.1449205","article-title":"Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage","volume":"32","author":"Holm","year":"2019","journal-title":"J Matern Fetal Neonatal Med"},{"key":"2025121221482059000_13.3.e069070.10","unstructured":"Peterson DF , Lancaster K , Yang C-J , et al . High rates of body iron store derangements and anemia above the transfusion threshold observed in patients following orthopaedic trauma. 2023."},{"key":"2025121221482059000_13.3.e069070.11","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2004.04088.x"},{"key":"2025121221482059000_13.3.e069070.12","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2005.00627.x"},{"key":"2025121221482059000_13.3.e069070.13","doi-asserted-by":"crossref","first-page":"153","DOI":"10.1111\/joim.13004","article-title":"Iron deficiency anaemia revisited","volume":"287","author":"Cappellini","year":"2020","journal-title":"J Intern Med"},{"key":"2025121221482059000_13.3.e069070.14","first-page":"8","article-title":"On the role of iron therapy for reducing allogeneic blood transfusion in orthopaedic surgery","volume":"10","author":"Mu\u00f1oz","year":"2012","journal-title":"Blood Transfus"},{"key":"2025121221482059000_13.3.e069070.15","doi-asserted-by":"crossref","first-page":"393","DOI":"10.2174\/187152810793938044","article-title":"The role of platelets in bone remodeling","volume":"9","author":"Sharif","year":"2010","journal-title":"Inflamm Allergy Drug Targets"},{"key":"2025121221482059000_13.3.e069070.16","doi-asserted-by":"publisher","DOI":"10.1007\/s11914-018-0423-2"},{"key":"2025121221482059000_13.3.e069070.17","doi-asserted-by":"publisher","DOI":"10.1016\/0002-9343(80)90383-6"},{"key":"2025121221482059000_13.3.e069070.18","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2018.202309"},{"key":"2025121221482059000_13.3.e069070.19","doi-asserted-by":"crossref","first-page":"670","DOI":"10.1089\/jwh.2019.7930","article-title":"A cross-sectional study of women and girls with congenital bleeding disorders: the American thrombosis and hemostasis network cohort","volume":"29","author":"Haley","year":"2020","journal-title":"J Womens Health (Larchmt)"},{"key":"2025121221482059000_13.3.e069070.20","doi-asserted-by":"publisher","DOI":"10.1542\/pir.2018-0359"},{"key":"2025121221482059000_13.3.e069070.21","doi-asserted-by":"crossref","first-page":"693","DOI":"10.1038\/pr.2017.298","article-title":"Pilot study of novel lab methodology and testing of platelet function in adolescent women with heavy menstrual bleeding","volume":"83","author":"Rocheleau","year":"2018","journal-title":"Pediatr Res"},{"key":"2025121221482059000_13.3.e069070.22","doi-asserted-by":"crossref","DOI":"10.1002\/rth2.12692","article-title":"Platelet reactivity and platelet count in women with iron deficiency treated with intravenous iron","volume":"6","author":"Elstrott","year":"2022","journal-title":"Res Pract Thromb Haemost"},{"key":"2025121221482059000_13.3.e069070.23","doi-asserted-by":"crossref","first-page":"8","DOI":"10.1159\/000496966","article-title":"Safety of oral and intravenous iron","volume":"142","author":"DeLoughery","year":"2019","journal-title":"Acta Haematol"},{"key":"2025121221482059000_13.3.e069070.24","doi-asserted-by":"crossref","DOI":"10.1001\/jamanetworkopen.2022.4488","article-title":"Analysis of adverse events and intravenous iron infusion formulations in adults with and without prior infusion reactions","volume":"5","author":"Arastu","year":"2022","journal-title":"JAMA Netw Open"},{"key":"2025121221482059000_13.3.e069070.25","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1016\/j.ajog.2018.12.016","article-title":"Oral vs intravenous iron therapy for postpartum anemia: a systematic review and meta-analysis","volume":"221","author":"Sultan","year":"2019","journal-title":"Am J Obstet Gynecol"},{"key":"2025121221482059000_13.3.e069070.26","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1111\/apt.15327","article-title":"Randomised clinical trial: intravenous vs oral iron for the treatment of anaemia after acute gastrointestinal bleeding","volume":"50","author":"Ferrer-Barcel\u00f3","year":"2019","journal-title":"Aliment Pharmacol Ther"},{"key":"2025121221482059000_13.3.e069070.27","doi-asserted-by":"crossref","first-page":"999","DOI":"10.1161\/ATVBAHA.120.314647","article-title":"Platelet proteomes, pathways, and phenotypes as informants of vascular wellness and disease","volume":"41","author":"Aslan","year":"2021","journal-title":"Arterioscler Thromb Vasc Biol"},{"key":"2025121221482059000_13.3.e069070.28","doi-asserted-by":"crossref","first-page":"2346","DOI":"10.1182\/blood.2020005496","article-title":"Phosphoproteomic quantitation and causal analysis reveal pathways in GPVI\/ITAM-mediated platelet activation programs","volume":"136","author":"Babur","year":"2020","journal-title":"Blood"},{"key":"2025121221482059000_13.3.e069070.29","doi-asserted-by":"publisher","DOI":"10.1016\/j.injury.2017.08.040"},{"key":"2025121221482059000_13.3.e069070.30","doi-asserted-by":"publisher","DOI":"10.3324\/haematol.2014.111492"},{"key":"2025121221482059000_13.3.e069070.31","doi-asserted-by":"crossref","DOI":"10.1182\/blood.V114.22.4054.4054","article-title":"Rapid (sixty minutes) infusion of one gram of low molecular iron dextran: safety and efficacy profile","volume":"114","author":"Auerbach","year":"2009","journal-title":"Blood"},{"key":"2025121221482059000_13.3.e069070.32","doi-asserted-by":"crossref","first-page":"1572","DOI":"10.1002\/ajh.25995","article-title":"A multicenter study evaluating the effectiveness and safety of single-dose low molecular weight iron dextran vs single-dose ferumoxytol for the treatment of iron deficiency","volume":"95","author":"Cohen","year":"2020","journal-title":"Am J Hematol"},{"key":"2025121221482059000_13.3.e069070.33","doi-asserted-by":"crossref","first-page":"467","DOI":"10.1097\/BOT.0000000000001245","article-title":"Patient-Reported outcomes measurement information system outcome measures and mental health in orthopaedic trauma patients during early recovery","volume":"32","author":"Vincent","year":"2018","journal-title":"J Orthop Trauma"},{"key":"2025121221482059000_13.3.e069070.34","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.e7586","article-title":"SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials","volume":"346","author":"Chan","year":"2013","journal-title":"BMJ"},{"key":"2025121221482059000_13.3.e069070.35","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.i5239","article-title":"Consort 2010 statement: extension to randomised pilot and feasibility trials","volume":"355","author":"Eldridge","year":"2016","journal-title":"BMJ"},{"key":"2025121221482059000_13.3.e069070.36","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.c332","article-title":"CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials","volume":"340","author":"Schulz","year":"2010","journal-title":"BMJ"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2022-069070","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T05:48:31Z","timestamp":1765604911000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2022-069070"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3]]},"references-count":36,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2023,3,21]]},"published-print":{"date-parts":[[2023,3]]}},"alternative-id":["10.1136\/bmjopen-2022-069070"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2022-069070","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3]]}}}