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

NCT07600905 — Completed, 134 participants, Shanghai Zhongshan Hospital

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

RegistryNCT07600905
StatusCompleted
Study typeObservational
Enrollment134 (Actual)
SponsorShanghai Zhongshan Hospital (Other)
ConditionsLiver Transplanatation, Postoperative Complication, Severe Thrombocytopenia
InterventionsAvatrombopag 20 mg Oral Tablet (Drug)
Datesstart 2019-11-01, primary completion 2025-08-31, completion 2025-08-31, first posted 2026-05-22, last updated 2026-08-28
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Liver Transplanatation All trials for Postoperative Complication All trials of Avatrombopag 20 mg Oral Tablet

-Summary

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).

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+Arms and interventions

ArmTypeInterventionsDescription
Arm 1: Avatrombopag Group / Arm 2: Control GroupDrug: Avatrombopag 20 mg Oral TabletArm 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
  • Avatrombopag 20 mg Oral Tablet (Drug): 40 mg orally once daily for 5 days, initiated when postoperative platelet count fell below 30×10⁹/L after liver transplatation

+Outcome measures

Primary outcomes

  • platelet rise rate [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.

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Zhongshan Hospital, Fudan UniversityShanghai, Shanghai MunicipalityChina