NCT07600905

Brief 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 (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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

5.8 years

First QC Date

May 16, 2026

Last Update Submit

May 16, 2026

Conditions

Liver TransplanatationPostoperative ComplicationSevere Thrombocytopenia

Keywords

AvatrombopagPlatelet recoveryLiver transplanatationSevere Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • platelet rise rate

    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.

    30 days post-LT

Secondary Outcomes (9)

  • Absolute platelet increase (×10⁹ cells/L)

    30 days post-Liver transplatation

  • Red blood cell transfusion volume (units)

    30 days post-Liver transplatation

  • Platelet transfusion volume (bags)

    30 days post-Liver transplatation

  • Concomitant thrombopoietic agent use

    30 days post-Liver transplatation

  • Infection (culture-proven + symptoms)

    30 days post-Liver transplatation

  • +4 more secondary outcomes

Study Arms (1)

Arm 1: Avatrombopag Group / Arm 2: Control Group

Arm 1: Avatrombopag Group. Standard postoperative care with 20 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

Drug: Avatrombopag 20 mg Oral Tablet

Interventions

Avatrombopag 20 mg Oral TabletDRUG

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

Arm 1: Avatrombopag Group / Arm 2: Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent liver transplantation at Zhongshan Hospital, Fudan University between November 2019 and August 2025

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Postoperative ComplicationsThrombocytopenia

Interventions

avatrombopagTablets

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2026

First Posted

May 22, 2026

Study Start

November 1, 2019

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)