此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Avatrombopag for Severe Thrombocytopenia After Liver Transplantation: A Retrospective Cohort Study

2026年8月26日 更新者:Shanghai Zhongshan Hospital

Effectiveness and Safety of Avatrombopag for Severe Post-Transplantation Thrombocytopenia in Liver Transplant Recipients: A Propensity-Score Matched Retrospective Cohort Study

Severe post-transplantation thrombocytopenia (platelet count <30×10⁹/L) occurs frequently after liver transplantation (LT) and is associated with increased bleeding risk, allograft dysfunction, and transfusion-related complications. Avatrombopag, an oral thrombopoietin receptor agonist, is approved for thrombocytopenia in chronic liver disease but its role in the post-LT setting remains unclear. This retrospective cohort study included adult LT recipients who developed severe post-transplantation thrombocytopenia (SPT) between November 2019 and August 2025. After 1:1 propensity score matching (nearest neighbor, caliper = 0.2 SD of the logit of the propensity score) for age, sex, etiology of liver disease, cold ischemia time (CIT), intraoperative blood loss (IBL), preoperative platelet count, and Model for End-stage Liver Disease (MELD) score, 67 patients who received avatrombopag (40 mg/day for 5 days) were compared with 67 matched controls who received standard care. The primary outcome was platelet rise rate (×10⁹/L/day). Secondary outcomes included absolute platelet increase, blood product utilization, concomitant thrombopoietic agent use, and 30-day complications (thrombosis, infection, mechanical ventilation, renal replacement therapy, death).

研究概览

研究类型

观察性的

注册 (实际的)

134

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200032
        • Zhongshan hospital, Fudan university

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients who underwent liver transplantation at Zhongshan Hospital, Fudan University between November 2019 and August 2025

描述

Inclusion Criteria: (1) were aged 18 years or older; and (2) developed severe post transplantation thrombocytopenia (SPT), defined as a nadir platelet count below 30×10⁹/L within the first 7 days after LT.

Exclusion criteria: (1) use of avatrombopag within 4 weeks before LT; (2) second or subsequent LT; (3) death from surgical complications within 7 days after LT; (4) incomplete platelet measurement records; and (5) age younger than 18 years.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Arm 1: Avatrombopag Group / Arm 2: Control Group

Arm 1: Avatrombopag Group. Standard postoperative care with 40 mg orally once daily for 5 days, initiated when postoperative platelet count fell below 30×10⁹/L.

Arm 2: Control Group. Standard postoperative care without avatrombopag

40 mg orally once daily for 5 days, initiated when postoperative platelet count fell below 30×10⁹/L after liver transplatation

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
platelet rise rate
大体时间:30 days post-LT
The platelet rise rate was calculated as (postoperative peak platelet count - postoperative nadir platelet count) divided by (time to peak - time to nadir + 1), measured in ×10⁹/L/day.
30 days post-LT

次要结果测量

结果测量
措施说明
大体时间
Absolute platelet increase (×10⁹ cells/L)
大体时间:30 days post-Liver transplatation
Postoperative peak minus postoperative nadir.
30 days post-Liver transplatation
Red blood cell transfusion volume (units)
大体时间:30 days post-Liver transplatation
Units of packed red blood cells transfused within 30 days after LT.
30 days post-Liver transplatation
Platelet transfusion volume (bags)
大体时间:30 days post-Liver transplatation
Bags of platelets transfused within 30 days after LT.
30 days post-Liver transplatation
Concomitant thrombopoietic agent use
大体时间:30 days post-Liver transplatation
Use of other thrombopoietic agents (e.g., recombinant human thrombopoietin), recorded as binary (yes/no).
30 days post-Liver transplatation
Infection (culture-proven + symptoms)
大体时间:30 days post-Liver transplatation
Presence of culture-confirmed infection with accompanying clinical symptoms within 30 days after LT.
30 days post-Liver transplatation
Mechanical ventilation requirement
大体时间:30 days post-Liver transplatation
Requirement for postoperative mechanical ventilation support.
30 days post-Liver transplatation
Renal replacement therapy requirement
大体时间:30 days post-Liver transplatation
Requirement for postoperative dialysis.
30 days post-Liver transplatation
Thrombotic events
大体时间:30 days post-Liver transplatation
Deep vein thrombosis or hepatic artery thrombosis.
30 days post-Liver transplatation
30-day mortality
大体时间:30 days post-Liver transplatation
All-cause death within 30 days after liver transplantation.
30 days post-Liver transplatation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年11月1日

初级完成 (实际的)

2025年8月31日

研究完成 (实际的)

2025年8月31日

研究注册日期

首次提交

2026年5月16日

首先提交符合 QC 标准的

2026年5月16日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅