Comparing the efficacy and safety of thromboprophylaxis with enoxaparin versus normal saline after liver transplantation: randomized clinical trial.

IF 8.8 1区医学 Q1 SURGERY British Journal of Surgery Pub Date : 2025-02-01 DOI:10.1093/bjs/znae325

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

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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.

Registration number: ChiCTR2000032441 (www.chictr.org.cn).

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比较肝移植术后依诺肝素与生理盐水预防血栓的疗效和安全性：随机临床试验。

背景：静脉血栓形成是死亡供肝移植后的一个重要并发症，但目前还没有确定的方案来预防死亡供肝移植后的血栓形成。本研究的目的是评估预防性抗凝在死亡供肝移植患者中的有效性和安全性。方法：对肝移植术后接受依诺肝素或生理盐水治疗的患者进行双中心随机对照试验。主要疗效指标为静脉血栓（门静脉血栓和深静脉血栓）发生率，主要安全性指标为大出血发生率。结果：共纳入462例患者。在意向治疗分析中，89例（19.3%）患者在移植后90天内出现静脉血栓形成，141例（30.5%）患者出现大出血。意向治疗组中，两组静脉血栓、门静脉血栓、深静脉血栓的发生率无显著差异。抗凝剂组大出血发生率明显升高（35.5% vs 25.5%, P = 0.020）。亚组分析显示，抗凝治疗与肝细胞癌患者深静脉血栓形成风险降低相关（HR 0.44 (95% ci . 0.23 ~ 0.86), P = 0.016），而大出血风险无显著升高。结论：使用依诺肝素预防性抗凝与死亡供肝移植患者大出血发生率显著升高相关，而不是降低静脉血栓形成的可能性。注册号：ChiCTR2000032441 （www.chictr.org.cn）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

British Journal of Surgery 医学-外科

CiteScore

12.70

自引率

7.30%

发文量

1102

审稿时长

1.5 months

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.