Kunlin Xie, Hongzhao Yang, Shouping Wang, Chenghan Xiao, Tian Lan, Hanyu Jiang, Sheyu Li, Huakang Tu, Jian Yang, Tao Lyv, Jianguo Qiu, Jing Zhou, Zhongwei Zhang, Chengyou Du, Xifeng Wu, Jiwei Huang, Ahmed M Elgendi, Alfred W C Kow, Jiayin Yang, Yong Zeng, Hong Wu
{"title":"Comparing the efficacy and safety of thromboprophylaxis with enoxaparin versus normal saline after liver transplantation: randomized clinical trial.","authors":"Kunlin Xie, Hongzhao Yang, Shouping Wang, Chenghan Xiao, Tian Lan, Hanyu Jiang, Sheyu Li, Huakang Tu, Jian Yang, Tao Lyv, Jianguo Qiu, Jing Zhou, Zhongwei Zhang, Chengyou Du, Xifeng Wu, Jiwei Huang, Ahmed M Elgendi, Alfred W C Kow, Jiayin Yang, Yong Zeng, Hong Wu","doi":"10.1093/bjs/znae325","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Venous thrombosis represents a significant complication after deceased-donor liver transplantation, yet there are currently no established protocols for thromboprophylaxis after deceased-donor liver transplantation. The aim of this study was to evaluate the efficacy and safety of prophylactic anticoagulation in patients undergoing deceased-donor liver transplantation.</p><p><strong>Methods: </strong>A dual-centre RCT of patients assigned to receive either enoxaparin or normal saline after liver transplantation was conducted. The primary efficacy outcome was the incidence of venous thrombosis (portal vein thrombosis and deep vein thrombosis) and the primary safety outcome was the incidence of major bleeding.</p><p><strong>Results: </strong>A total of 462 patients were recruited. In the intention-to-treat analysis, 89 patients (19.3%) experienced venous thrombosis and 141 patients (30.5%) experienced major bleeding within 90 days after transplantation. No significant differences were observed in the incidence of venous thrombosis, portal vein thrombosis, or deep vein thrombosis between the two groups in the intention-to-treat cohort. The anticoagulant group demonstrated a markedly elevated incidence of major bleeding (35.5% versus 25.5%, P = 0.020). Subgroup analysis revealed that anticoagulation was associated with a lower risk of deep vein thrombosis in hepatocellular carcinoma patients (HR 0.44 (95% c.i. 0.23 to 0.86), P = 0.016), without a significantly higher risk of major bleeding.</p><p><strong>Conclusion: </strong>Use of prophylactic anticoagulation with enoxaparin is associated with a significantly higher incidence of major bleeding in patients undergoing deceased-donor liver transplantation, rather than a lower likelihood of venous thrombosis.</p><p><strong>Registration number: </strong>ChiCTR2000032441 (www.chictr.org.cn).</p>","PeriodicalId":136,"journal":{"name":"British Journal of Surgery","volume":"112 2","pages":""},"PeriodicalIF":8.6000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11848516/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"British Journal of Surgery","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/bjs/znae325","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Venous thrombosis represents a significant complication after deceased-donor liver transplantation, yet there are currently no established protocols for thromboprophylaxis after deceased-donor liver transplantation. The aim of this study was to evaluate the efficacy and safety of prophylactic anticoagulation in patients undergoing deceased-donor liver transplantation.
Methods: A dual-centre RCT of patients assigned to receive either enoxaparin or normal saline after liver transplantation was conducted. The primary efficacy outcome was the incidence of venous thrombosis (portal vein thrombosis and deep vein thrombosis) and the primary safety outcome was the incidence of major bleeding.
Results: A total of 462 patients were recruited. In the intention-to-treat analysis, 89 patients (19.3%) experienced venous thrombosis and 141 patients (30.5%) experienced major bleeding within 90 days after transplantation. No significant differences were observed in the incidence of venous thrombosis, portal vein thrombosis, or deep vein thrombosis between the two groups in the intention-to-treat cohort. The anticoagulant group demonstrated a markedly elevated incidence of major bleeding (35.5% versus 25.5%, P = 0.020). Subgroup analysis revealed that anticoagulation was associated with a lower risk of deep vein thrombosis in hepatocellular carcinoma patients (HR 0.44 (95% c.i. 0.23 to 0.86), P = 0.016), without a significantly higher risk of major bleeding.
Conclusion: Use of prophylactic anticoagulation with enoxaparin is associated with a significantly higher incidence of major bleeding in patients undergoing deceased-donor liver transplantation, rather than a lower likelihood of venous thrombosis.
期刊介绍：
The British Journal of Surgery (BJS), incorporating the European Journal of Surgery, stands as Europe's leading peer-reviewed surgical journal. It serves as an invaluable platform for presenting high-quality clinical and laboratory-based research across a wide range of surgical topics. In addition to providing a comprehensive coverage of traditional surgical practices, BJS also showcases emerging areas in the field, such as minimally invasive therapy and interventional radiology.
While the journal appeals to general surgeons, it also holds relevance for specialty surgeons and professionals working in closely related fields. By presenting cutting-edge research and advancements, BJS aims to revolutionize the way surgical knowledge is shared and contribute to the ongoing progress of the surgical community.
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