- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07600905
Avatrombopag for Severe Thrombocytopenia After Liver Transplantation: A Retrospective Cohort Study
Effectiveness and Safety of Avatrombopag for Severe Post-Transplantation Thrombocytopenia in Liver Transplant Recipients: A Propensity-Score Matched Retrospective Cohort Study
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200032
- Zhongshan Hospital, Fudan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 |
20 mg orally once daily for 5 days, initiated when postoperative platelet count fell below 30×10⁹/L after liver transplatation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 days post-LT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Absolute platelet increase (×10⁹ cells/L)
Time Frame: 30 days post-Liver transplatation
|
Postoperative peak minus postoperative nadir.
|
30 days post-Liver transplatation
|
|
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.
|
30 days post-Liver transplatation
|
|
Platelet transfusion volume (bags)
Time Frame: 30 days post-Liver transplatation
|
Bags of platelets transfused within 30 days after LT.
|
30 days post-Liver transplatation
|
|
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).
|
30 days post-Liver transplatation
|
|
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.
|
30 days post-Liver transplatation
|
|
Mechanical ventilation requirement
Time Frame: 30 days post-Liver transplatation
|
Requirement for postoperative mechanical ventilation support.
|
30 days post-Liver transplatation
|
|
Renal replacement therapy requirement
Time Frame: 30 days post-Liver transplatation
|
Requirement for postoperative dialysis.
|
30 days post-Liver transplatation
|
|
Thrombotic events
Time Frame: 30 days post-Liver transplatation
|
Deep vein thrombosis or hepatic artery thrombosis.
|
30 days post-Liver transplatation
|
|
30-day mortality
Time Frame: 30 days post-Liver transplatation
|
All-cause death within 30 days after liver transplantation.
|
30 days post-Liver transplatation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2026-303
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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