{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T06:55:11Z","timestamp":1792133711438,"version":"4.4.0"},"reference-count":14,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2024,2,12]],"date-time":"2024-02-12T00:00:00Z","timestamp":1707696000000},"content-version":"unspecified","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Chinese Academy of Medical Sciences (CAMS) Innovation Fund for Medical Sciences","award":["2022-I2M-C&T-B-031"],"award-info":[{"award-number":["2022-I2M-C&T-B-031"]}]},{"name":"National High Level Hospital Clinical Research Funding","award":["2022-PUMCH-A-124"],"award-info":[{"award-number":["2022-PUMCH-A-124"]}]},{"name":"Beijing Natural Science Foundation","award":["L232006"],"award-info":[{"award-number":["L232006"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"published-print":{"date-parts":[[2024,2]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>Total knee arthroplasty (TKA) is a common surgical intervention to treat joint diseases. However, TKA is associated with significant blood loss. Tranexamic acid (TXA) has been used to reduce perioperative bleeding and postoperative blood transfusion. This study aims to explore the effectiveness and safety of intraosseous regional administration (IORA) of TXA in TKA and compare differences in perioperative blood loss between IORA of TXA, intravenous infusion of TXA, and combined IORA and intravenous infusion of TXA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and analysis<\/jats:title><jats:p>This randomised controlled trial will enrol 105 patients with osteoarthritis who meet the inclusion criteria for unilateral TKA. Patients were randomly divided into three groups using the random number table method. Group A received 1.0\u2009g of TXA via IORA, group B received 1.0\u2009g of TXA via intravenous infusion 15\u2009min prior to the tourniquet release, and group C received both IORA of 1.0\u2009g of TXA and intravenous infusion of 1.0\u2009g of TXA. The primary outcome measure is perioperative total blood loss. Secondary outcomes include bleeding events, venous thromboembolism events, inflammation reactions, other complications and knee function assessments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Ethics and dissemination<\/jats:title><jats:p>This study has been approved by the Ethics Committee of Peking Union Medical College Hospital and registered in the Chinese Clinical Trial Registry. Informed consent will be obtained from all the patients before enrolment. The trial will be conducted in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines. The results of this study will be disseminated through peer-reviewed publications, conference presentations and social media platforms. The findings will provide valuable insights into the use of IORA of TXA in TKA and may lead to the development of new strategies for perioperative blood management in joint replacement surgery.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p>The Ethics Committee of Peking Union Medical College Hospital (approval number: K2371); Chinese Clinical Trial Registry (trial registration number: ChiCTR2200066293).<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2023-077393","type":"journal-article","created":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T02:11:48Z","timestamp":1707790308000},"page":"e077393","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":5,"title":["Impact of intraosseous regional administration of tranexamic acid in total knee arthroplasty on perioperative blood loss: a protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1045-4917","authenticated-orcid":false,"given":"Zhanqi","family":"Wei","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muyang","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yiming","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xisheng","family":"Weng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bin","family":"Feng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2024,2,12]]},"reference":[{"key":"2024021218102719000_14.2.e077393.1","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1016\/j.arth.2009.11.013","article-title":"Tranexamic acid to reduce blood loss after bilateral total knee arthroplasty: A prospective, randomized double blind study","volume":"26","author":"MacGillivray","year":"2011","journal-title":"J Arthroplasty"},{"key":"2024021218102719000_14.2.e077393.2","doi-asserted-by":"crossref","first-page":"169","DOI":"10.1097\/00003086-200002000-00021","article-title":"Effect of tourniquet use on activation of coagulation in total knee replacement","volume":"2000","author":"Aglietti","year":"2000","journal-title":"Clin Orthop Relat Res"},{"key":"2024021218102719000_14.2.e077393.3","first-page":"88","article-title":"Does tranexamic acid reduce blood loss in knee arthroplasty?","volume":"8","author":"Benoni","year":"1995","journal-title":"Am J Knee Surg"},{"key":"2024021218102719000_14.2.e077393.4","doi-asserted-by":"publisher","DOI":"10.2106\/JBJS.J.01048"},{"key":"2024021218102719000_14.2.e077393.5","doi-asserted-by":"publisher","DOI":"10.1007\/s00167-012-2079-2"},{"key":"2024021218102719000_14.2.e077393.6","doi-asserted-by":"publisher","DOI":"10.1007\/s00264-010-1205-3"},{"key":"2024021218102719000_14.2.e077393.7","doi-asserted-by":"publisher","DOI":"10.1016\/j.arth.2012.11.016"},{"key":"2024021218102719000_14.2.e077393.8","doi-asserted-by":"publisher","DOI":"10.1016\/j.arth.2014.10.007"},{"key":"2024021218102719000_14.2.e077393.9","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1016\/j.arth.2014.01.038","article-title":"Weighted versus uniform dose of tranexamic acid in patients undergoing primary, elective knee arthroplasty: A prospective randomized controlled trial","volume":"29","author":"Levine","year":"2014","journal-title":"J Arthroplasty"},{"key":"2024021218102719000_14.2.e077393.10","doi-asserted-by":"crossref","first-page":"3573","DOI":"10.1007\/s11999-015-4464-x","article-title":"Regional Intraosseous Administration of Prophylactic Antibiotics is More Effective Than Systemic Administration in a Mouse Model of TKA","volume":"473","author":"Young","year":"2015","journal-title":"Clin Orthop Relat Res"},{"key":"2024021218102719000_14.2.e077393.11","doi-asserted-by":"crossref","first-page":"66","DOI":"10.1007\/s11999.0000000000000013","article-title":"The John N. Insall Award: Higher Tissue Concentrations of Vancomycin Achieved With Intraosseous Regional Prophylaxis in Revision TKA: A Randomized Controlled Trial","volume":"476","author":"Young","year":"2018","journal-title":"Clin Orthop Relat Res"},{"key":"2024021218102719000_14.2.e077393.12","doi-asserted-by":"crossref","first-page":"848","DOI":"10.1111\/ans.14816","article-title":"Use of regional administration of prophylactic antibiotics in total knee arthroplasty","volume":"88","author":"Symonds","year":"2018","journal-title":"ANZ J Surg"},{"key":"2024021218102719000_14.2.e077393.13","doi-asserted-by":"crossref","first-page":"3474","DOI":"10.1007\/s00167-016-4053-x","article-title":"Computer navigation is effective in reducing blood loss but has no effect on transfusion requirement following primary total knee arthroplasty: a meta-analysis","volume":"24","author":"Han","year":"2016","journal-title":"Knee Surg Sports Traumatol Arthrosc"},{"key":"2024021218102719000_14.2.e077393.14","first-page":"1","article-title":"Expert consensus in enhanced recovery after total knee arthroplasty in China","volume":"9","author":"Zhou","year":"2016","journal-title":"Chinese Journal Bone and Joint Surgery"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2023-077393","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,2,13]],"date-time":"2024-02-13T02:12:01Z","timestamp":1707790321000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2023-077393"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,2]]},"references-count":14,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2024,2,12]]},"published-print":{"date-parts":[[2024,2]]}},"alternative-id":["10.1136\/bmjopen-2023-077393"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2023-077393","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,2]]}}}