What question did this study set out to answer?

To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) for improving outcomes in septic ICU patients with severe thrombocytopenia.

March 26, 2026

836: Multicenter RCT of Recombinant Human Thrombopoietin for Icu Sepsis With Severe Thrombocytopenia

Key Points

To evaluate the efficacy and safety of recombinant human thrombopoietin (rhTPO) for improving outcomes in septic ICU patients with severe thrombocytopenia.
Conducted a multicenter, open-label randomized controlled trial (RCT)
Enrolled 204 septic patients with severe thrombocytopenia across 8 ICUs in China
Administered rhTPO 15,000 U/day for 7 days to one group and placebo to another
Assessed primary endpoint of 28-day all-cause mortality and various secondary endpoints
28-day mortality was 17.3% in the rhTPO group versus 24.4% in the placebo group, not statistically significant
Significant reduction in mortality observed in patients under 65 with specific health criteria
rhTPO showed an upward trend in platelet counts, with faster recovery in younger patients
Safety profile comparable between groups, with no increase in bleeding or thromboembolism risks

Abstract

Introduction: Severe thrombocytopenia (7 days. Recombinant human thrombopoietin (rhTPO) may restore platelet counts and improve outcomes, but its efficacy and safety remain unproven. Methods: Multicenter, open-label RCT (Apr 2019–Dec 2024) in 8 Chinese ICUs randomized 204 septic patients with severe thrombocytopenia (< 50×109/L) to rhTPO 15,000 U/day for 7 days (n=101) or placebo (n=103). The primary endpoint was 28-day all-cause mortality, and secondary endpoints included platelet count changes, clinical platelet recovery time, blood product transfusion volume, infection biomarkers, and organ function indicators. Results: A total of 188 patients (98 in the rhTPO group and 90 in the placebo group) were included in the modified intention-to-treat analysis, with balanced baseline characteristics between groups. For the primary endpoint, the 28-day mortality was 17.3% (17/98) in the rhTPO group and 24.4% (22/90) in the placebo group, with a hazard ratio (HR) of 0.82 (95% confidence interval CI: 0.53-1.27, P=0.308), without statistical significance. Subgroup analysis showed that rhTPO significantly reduced 28-day mortality in patients < 65 years old, with systolic blood pressure ≥118 mmHg, and total bilirubin < 28 μmol/L (P< 0.05). In terms of platelet dynamics, the rhTPO group showed an upward trend in platelet counts on days 10 and 14 (P=0.069 and P=0.09), and platelet recovery was faster in patients < 65 years old (P< 0.05). In terms of safety, the incidence of adverse events was similar between the two groups, and rhTPO did not increase the risk of bleeding or thromboembolism. Conclusions: rhTPO did not show overall survival benefit in unselected septic patients with severe thrombocytopenia, but it may accelerate platelet recovery and reduce mortality in specific subgroups (aged < 65 years, stable systolic blood pressure, and low total bilirubin) with good safety. Future biomarker-stratified trials are needed to further validate and optimize the precision application of rhTPO in septic patients.

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Cite This Study

Zhou et al. (Sun,) studied this question.

synapsesocial.com/papers/69c4cda5fdc3bde44891a4e7 https://doi.org/https://doi.org/10.1097/01.ccm.0001185340.65899.43

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