2026/07/28 by Yifan Han, Ning Lin, Jinghang Xu +46
Medicine · #Blood transfusion and management #Platelet Disorders and Treatments #Trauma, Hemostasis, Coagulopathy, Resuscitation
paper · doi:10.1002/ajh.70444
openalex publication_date 2026/07/28 · openalex created_date 2026/07/29 · openalex updated_date 2026/07/29
ABSTRACT Chronic liver disease (CLD)‐related thrombocytopenia can limit the feasibility of invasive procedures. Recombinant human thrombopoietin (rhTPO) has demonstrated a favorable safety profile without hepatotoxicity. We evaluated the efficacy and safety of rhTPO in patients with CLD‐related thrombocytopenia who were undergoing elective invasive procedures. In this multicenter, randomized (2:1), double‐blind, placebo‐controlled phase III trial, 120 adult Chinese patients with CLD‐related thrombocytopenia (platelet count < 50 × 10 9 /L) received rhTPO ( n = 80) or placebo ( n = 40) once daily for up to 5 or 7 days. The primary endpoint was the proportion of patients with sustained platelet counts ≥ 50 × 10 9 /L from 24 h before invasive procedure to 7 days post‐procedure, without requiring emergency bleeding management. The primary endpoint was achieved by 85.0% of patients in the rhTPO group versus 12.5% in the placebo group ( p < 0.0001). Preoperatively, platelet counts ≥ 50 × 10 9 /L were achieved in 92.5% and 20.0% of patients in the rhTPO and placebo groups, respectively ( p < 0.0001). Platelet transfusion was avoided in 92.5% of rhTPO‐treated patients versus 25.0% of placebo‐treated patients ( p < 0.0001). The median duration of platelet counts ≥ 50 × 10 9 /L was significantly longer with rhTPO than with placebo (21.0 vs. 3.0 days, p = 0.0007). Treatment‐related treatment‐emergent adverse events (TEAEs) occurred in 12.5% of patients in both the rhTPO and placebo groups. No treatment‐related serious adverse events were reported. Overall, rhTPO was effective and well tolerated in patients with CLD‐related thrombocytopenia and may represent a viable therapeutic option for those undergoing elective invasive procedures. Trial Registration: www.chinadrugtrials.org.cn : number CTR20230919.