{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,6]],"date-time":"2026-01-06T02:05:03Z","timestamp":1767665103703,"version":"3.48.0"},"reference-count":43,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2023,12,18]],"date-time":"2023-12-18T00:00:00Z","timestamp":1702857600000},"content-version":"unspecified","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Medical Innovation Research Special Project of 2023 \"Science and Technology Innovation Action Plan\" of Shanghai","award":["23Y11903500"],"award-info":[{"award-number":["23Y11903500"]}]},{"name":"Health Profession Clinical Research Specialty of Shanghai Municipal Health Commission","award":["20234Y0032"],"award-info":[{"award-number":["20234Y0032"]}]},{"name":"General Project of Shanghai Municipal Health Commission","award":["202040399"],"award-info":[{"award-number":["202040399"]}]},{"name":"Clinical Research Program of Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine","award":["ynts202202, ynhg202202"],"award-info":[{"award-number":["ynts202202, ynhg202202"]}]},{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","award":["82002292, 82330076"],"award-info":[{"award-number":["82002292, 82330076"]}],"id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Shanghai Engineering Technology Research Center and Professional Technology Service Platform Project of 2020 \"Science and Technology Innovation Action Plan\" of Shanghai","award":["20DZ2254100"],"award-info":[{"award-number":["20DZ2254100"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2023,11,21]]},"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Exaggerated inflammatory response is one of the main mechanisms underlying heterotopic ossification (HO). It has been suggested that the antifibrinolytic drug tranexamic acid (TXA) can exert a significant anti-inflammatory effect during orthopaedic surgery. However, no prospective studies have yet investigated the effects of TXA on HO recurrence in patients following open elbow arthrolysis (OEA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>Here, we present a protocol for a single-centre, randomised, double-blind, placebo-controlled trial to investigate the effectiveness of TXA on HO recurrence after OEA in a single hospital. A minimum sample size of 138 eligible and consenting participants randomised into treatment and control groups in a 1:1 manner will be included. Patients will receive 2\u2009g of intravenous TXA (experimental group) or placebo (normal saline, control group) administered before skin incision. The primary outcome is HO recurrence rate within 12 months after surgery. The secondary outcomes are the serum immune-inflammatory cytokines including erythrocyte sedimentation rate, C reactive protein, interleukin (IL)-6, IL-1\u03b2, IL-13 at the first and third day postoperatively, and elbow range of motion and functional score at 1.5, 6, 9 and 12 months after surgery. After completion of the trial, the results will be reported in accordance with the extensions of the Consolidated Standards of Reporting Trials Statement for trials. The results of this study should determine whether TXA can reduce the rates of HO occurrence after OEA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethical approval has been granted by the Medical Ethics Committee of the Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (reference number 2022-123-(1)). The results of this study will be disseminated through presentations at academic conferences and publication in peer-reviewed journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>ChiCTR2300068106.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2023-075502","type":"journal-article","created":{"date-parts":[[2023,12,18]],"date-time":"2023-12-18T22:36:27Z","timestamp":1702938987000},"page":"e075502","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Tranexamic acid in patients with post-traumatic elbow stiffness: protocol for a randomised, double-blind, placebo-controlled trial investigating the effectiveness of tranexamic acid at reducing the recurrence of heterotopic ossification after open elbow 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China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yin","family":"Wang","sequence":"additional","affiliation":[{"name":"Nursing Department, Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Min","family":"Luan","sequence":"additional","affiliation":[{"name":"Clinical Research Center, Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kuangyu","family":"He","sequence":"additional","affiliation":[{"name":"Department of Orthopedics, Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"},{"name":"Shanghai Engineering Research Center for Orthopaedic Material Innovation and Tissue Regeneration, Shanghai, 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People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"},{"name":"Shanghai Engineering Research Center for Orthopaedic Material Innovation and Tissue Regeneration, Shanghai, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8673-9521","authenticated-orcid":false,"given":"Ziyang","family":"Sun","sequence":"additional","affiliation":[{"name":"Department of Orthopedics, Shanghai Sixth People\u2019s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China"},{"name":"Shanghai Engineering Research Center for Orthopaedic Material Innovation and Tissue Regeneration, Shanghai, China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3724-0174","authenticated-orcid":false,"given":"Shuai","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Orthopedics, Shanghai Sixth People\u2019s Hospital 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