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Completed

NCT Number: NCT07600905

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

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 (20 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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avatrombopag 20 mg Oral Tablet

Drug

20 mg orally once daily for 5 days, initiated when postoperative platelet count fell below 30×10⁹/L after liver transplatation

Primary outcomes

  1. platelet rise rate

    Time frame: 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

  1. Absolute platelet increase (×10⁹ cells/L)

    Time frame: 30 days post-Liver transplatation

    Postoperative peak minus postoperative nadir.

  2. Red blood cell transfusion volume (units)

    Time frame: 30 days post-Liver transplatation

    Units of packed red blood cells transfused within 30 days after LT.

  3. Platelet transfusion volume (bags)

    Time frame: 30 days post-Liver transplatation

    Bags of platelets transfused within 30 days after LT.

  4. Concomitant thrombopoietic agent use

    Time frame: 30 days post-Liver transplatation

    Use of other thrombopoietic agents (e.g., recombinant human thrombopoietin), recorded as binary (yes/no).

  5. Infection (culture-proven + symptoms)

    Time frame: 30 days post-Liver transplatation

    Presence of culture-confirmed infection with accompanying clinical symptoms within 30 days after LT.

  6. Mechanical ventilation requirement

    Time frame: 30 days post-Liver transplatation

    Requirement for postoperative mechanical ventilation support.

  7. Renal replacement therapy requirement

    Time frame: 30 days post-Liver transplatation

    Requirement for postoperative dialysis.

  8. Thrombotic events

    Time frame: 30 days post-Liver transplatation

    Deep vein thrombosis or hepatic artery thrombosis.

  9. 30-day mortality

    Time frame: 30 days post-Liver transplatation

    All-cause death within 30 days after liver transplantation.

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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