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 arthrolysis
Introduction 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 studi...
| Main Authors: | , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-12-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e075502.full |
| _version_ | 1797370858335895552 |
|---|---|
| author | Yin Wang Wei Wang Shuai Chen Haomin Cui Gang Luo Ziyang Sun Cunyi Fan Min Luan Kuangyu He Jihao Ruan Juehong Li Tengfei Lou Shiyang Yu |
| author_facet | Yin Wang Wei Wang Shuai Chen Haomin Cui Gang Luo Ziyang Sun Cunyi Fan Min Luan Kuangyu He Jihao Ruan Juehong Li Tengfei Lou Shiyang Yu |
| author_sort | Yin Wang |
| collection | DOAJ |
| description | Introduction 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).Methods and analysis 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 g 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-1β, 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.Ethics and dissemination Ethical approval has been granted by the Medical Ethics Committee of the Shanghai Sixth People’s 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.Trial registration number ChiCTR2300068106. |
| first_indexed | 2024-03-08T18:10:26Z |
| format | Article |
| id | doaj.art-50be48a70c5f488da7158f839f9dc303 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-08T18:10:26Z |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-50be48a70c5f488da7158f839f9dc3032024-01-01T08:25:08ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-075502Tranexamic 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 arthrolysisYin Wang0Wei Wang1Shuai Chen2Haomin Cui3Gang Luo4Ziyang Sun5Cunyi Fan6Min Luan7Kuangyu He8Jihao Ruan9Juehong Li10Tengfei Lou11Shiyang Yu12Nursing Department, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaKey Laboratory of Environmental Medicine and Engineering of Ministry of Education, Department of Epidemiology and Health Statistics, School of Public Health, Southeast University, Nanjing, ChinaDepartment of Orthopedics, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaOrthopedic Surgery, Shanghai Jiaotong University Affiliated Sixth People Hospital South Campus, Shanghai, China1 Department of Intervention, Interventional Neuroradiology Center, Beijing Tiantan Hospital, Capital Medical University, Beijing, ChinaShanghai Engineering Research Center for Orthopaedic Material Innovation and Tissue Regeneration, Shanghai, ChinaShanghai Engineering Research Center for Orthopaedic Material Innovation and Tissue Regeneration, Shanghai, ChinaClinical Research Center, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Orthopedics, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Orthopedics, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Orthopedics, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Orthopedics, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Orthopedics, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaIntroduction 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).Methods and analysis 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 g 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-1β, 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.Ethics and dissemination Ethical approval has been granted by the Medical Ethics Committee of the Shanghai Sixth People’s 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.Trial registration number ChiCTR2300068106.https://bmjopen.bmj.com/content/13/12/e075502.full |
| spellingShingle | Yin Wang Wei Wang Shuai Chen Haomin Cui Gang Luo Ziyang Sun Cunyi Fan Min Luan Kuangyu He Jihao Ruan Juehong Li Tengfei Lou Shiyang Yu 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 arthrolysis BMJ Open |
| 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 arthrolysis |
| title_full | 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 arthrolysis |
| title_fullStr | 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 arthrolysis |
| title_full_unstemmed | 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 arthrolysis |
| title_short | 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 arthrolysis |
| title_sort | 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 arthrolysis |
| url | https://bmjopen.bmj.com/content/13/12/e075502.full |
| work_keys_str_mv | AT yinwang tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT weiwang tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT shuaichen tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT haomincui tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT gangluo tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT ziyangsun tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT cunyifan tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT minluan tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT kuangyuhe tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT jihaoruan tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT juehongli tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT tengfeilou tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis AT shiyangyu tranexamicacidinpatientswithposttraumaticelbowstiffnessprotocolforarandomiseddoubleblindplacebocontrolledtrialinvestigatingtheeffectivenessoftranexamicacidatreducingtherecurrenceofheterotopicossificationafteropenelbowarthrolysis |