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Abstract <p>Transplant-associated thrombotic microangiopathy (TA-TMA) remains a severe complication after allogeneic hematopoietic cell transplantation (allo-HCT). Early prediction of high-risk patients remains challenging, particularly in adults. This prospective observational study consecutively enrolled patients aged &gt;14 years undergoing allo-HCT. TA-TMA was screened and diagnosed according to the harmonization criteria. The 100-day cumulative incidence of TA-TMA was 6.5% (95% CI 4.5–8.9%). Multivariable analyses identified elevated baseline endothelial activation and stress index (EASIX, HR 1.33, <i>p</i> = 0.011) and day 14 sC5b-9 (HR 2.84, <i>p</i> &lt; 0.001) were independently associated with TA-TMA. The optimal cutoff was 217 ng/mL for sC5b-9 and 6.2 for EASIX. Using the cutoffs for the combined EASIX and sC5b-9, patients were stratified into low-, intermediate-, and high-risk groups, with corresponding 100-day incidences of 2.2%, 7.1%, and 32.4%. Compared with the low-risk group, the intermediate- and high-risk groups showed increased risk of TA-TMA (HR 3.29, 95% CI 1.39–7.79; HR 14.32, 95% CI 5.62–36.50, respectively). The risk stratification system showed moderate discrimination, with a time-dependent AUC of 0.75 (95% CI 0.66–0.84). Therefore, baseline EASIX and day14 sC5b-9 were significantly associated with TA-TMA, and their combination may improve early identification of adult patients at high-risk of developing TA-TMA.</p> Trial registration <p>Name of the registry: ClinicalTrials.gov. Trial registration number: NCT06102694. The date that we registered the trial: 10/22/2023. URL of trial registry record: <a href="https://clinicaltrials.gov/study/NCT06102694?cond=NCT06102694&amp;rank=1">https://clinicaltrials.gov/study/NCT06102694?cond=NCT06102694&amp;rank=1</a>.</p>

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EASIX and sC5b-9 for early identification of adults at high risk of developing TA-TMA after allo-HCT

  • 期刊论文

  • 发表日期：

    2026年7月24日

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  • Wenwen Guo,
  • Shulian Chen,
  • Xiaoyu Zhang,
  • Mingyue Xu,
  • Xianjing Zhang,
  • Jiali Wang,
  • Yawei Zheng,
  • Yuyan Shen,
  • Qingzhen Liu,
  • Xiaofei Ni,
  • Mengnan Lv,
  • Tingting Zhang,
  • Yuanyuan Shi,
  • Fengjiao Wang,
  • Xiaoli Zhao,
  • Jialin Wei,
  • Rongli Zhang,
  • Xin Chen,
  • Yigeng Cao,
  • Yong Li,
  • Yueyi Mu,
  • Aiming Pang,
  • Mingzhe Han,
  • Guoqing Zhu,
  • Wenbin Cao,
  • Erlie Jiang

摘要

Abstract

Transplant-associated thrombotic microangiopathy (TA-TMA) remains a severe complication after allogeneic hematopoietic cell transplantation (allo-HCT). Early prediction of high-risk patients remains challenging, particularly in adults. This prospective observational study consecutively enrolled patients aged >14 years undergoing allo-HCT. TA-TMA was screened and diagnosed according to the harmonization criteria. The 100-day cumulative incidence of TA-TMA was 6.5% (95% CI 4.5–8.9%). Multivariable analyses identified elevated baseline endothelial activation and stress index (EASIX, HR 1.33, p = 0.011) and day 14 sC5b-9 (HR 2.84, p < 0.001) were independently associated with TA-TMA. The optimal cutoff was 217 ng/mL for sC5b-9 and 6.2 for EASIX. Using the cutoffs for the combined EASIX and sC5b-9, patients were stratified into low-, intermediate-, and high-risk groups, with corresponding 100-day incidences of 2.2%, 7.1%, and 32.4%. Compared with the low-risk group, the intermediate- and high-risk groups showed increased risk of TA-TMA (HR 3.29, 95% CI 1.39–7.79; HR 14.32, 95% CI 5.62–36.50, respectively). The risk stratification system showed moderate discrimination, with a time-dependent AUC of 0.75 (95% CI 0.66–0.84). Therefore, baseline EASIX and day14 sC5b-9 were significantly associated with TA-TMA, and their combination may improve early identification of adult patients at high-risk of developing TA-TMA.

Trial registration

Name of the registry: ClinicalTrials.gov. Trial registration number: NCT06102694. The date that we registered the trial: 10/22/2023. URL of trial registry record: https://clinicaltrials.gov/study/NCT06102694?cond=NCT06102694&rank=1.