Short-term hetrombopag for the management of preoperative thrombocytopenia: A multicenter clinical trial

Abstract

Abstract OBJECTIVE: Preoperative thrombocytopenia critically influences surgical outcomes. Rapidly elevating platelet count to meet perioperative threshold is essential to reduce bleeding risk and shorten the waiting time to surgery. This study evaluated whether hetrombopag could increase the platelet count to target surgical level within a 2-week preoperative period. METHODS: Patients with immune thrombocytopenia (ITP) scheduled for surgery whoseplatelet count was insufficient to meet preoperative requirement (<50×10⁹/L for minor surgery or <80×10⁹/L for major surgery) and fulfilled the inclusion/exclusion criteria received hetrombopag 7.5 mg daily for 14 days. Complete blood counts were assessed on days 7 and 14. Emergency platelet transfusions were administered based on bleeding risk. The primary endpoint was the proportion of patients achieving target platelet count (≥80×10⁹/L for major surgery or ≥50×10⁹/L for minor surgery) without emergency platelet transfusion. Clinical Trial Registration Number: NCT06562738. RESULTS: Among 42 patients analyzed, theoverall achievement rate was 85.7% (36/42; 95% CI: 75.1%–96.3%) within 2-week. By day 7, 68.2% (15/22) of patients with minor surgery and 65.0% (13/20) of patients with major surgery achieved the target platelet count. Univariate logistic regression was used to evaluate factors associated with achieving the desired threshold. Patients were categorized into high-difference subgroup (difference ≥50×10⁹/L) and low-difference subgroup (difference <50×10⁹/L) according the baseline platelet count difference from the desired threshold. The achievement rate was 72.7% (8/11) in high-difference subgroup and 90.3% (28/31) in low-difference subgroup. The high-difference subgroup showed a non-significant trend toward lower achievement rate (odds ratio [OR] = 0.286; 95% CI: 0.054–1.520; P = 0.168). Among patients with prior thrombopoietin receptor agonist (TPO-RA) use, the rate of achieving the target platelet count was 78.9% (15/19). The achievement rate was 91.3% (21/23) in those without prior TPO-RA use. Prior TPO-RA use was not significantly associated with the achievement of target platelet count (OR = 0.357; 95% CI: 0.062–2.050; P = 0.268). Three patients developed elevated transaminases (one >2× upper limit of normal [ULN], resolved with treatment), with no elevations exceeding 3× ULN.CONCLUSION: Hetrombopag 7.5 mg daily demonstrated a high overall achievement rate (85.7%) for increment of platelet count to the desired threshold within 14 days before surgery. Success was unaffected by baseline-target difference or prior TPO-RA exposure in this cohort.