Liver TransplanatationNCT07600905
Avatrombopag for Severe Thrombocytopenia After Liver Transplantation: A Retrospective Cohort Study
An observational study of Liver Transplanatation and Postoperative Complication, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplanatation, Postoperative Complication, Severe Thrombocytopenia
- What is being tested?
- Avatrombopag 20 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2019to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who underwent liver transplantation at Zhongshan Hospital, Fudan University between November 2019 and August 2025
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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Effectiveness and Safety of Avatrombopag for Severe Post-Transplantation Thrombocytopenia in Liver Transplant Recipients: A Propensity-Score Matched 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 (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).
- Being tested
- Avatrombopag 20 mg Oral Tablet
- Keywords
- Avatrombopag, Platelet recovery, Liver transplanatation, Severe Thrombocytopenia
- Medical subject headings
- Postoperative Complications, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avatrombopag 20 mg Oral TabletDrug
40 mg orally once daily for 5 days, initiated when postoperative platelet count fell below 30×10⁹/L after liver transplatation
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Avatrombopag Group / Arm 2: Control Group | Arm 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 Receives: Drug: Avatrombopag 20 mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days post-LT
Secondary outcomes (9)
Absolute platelet increase (×10⁹ cells/L)
Postoperative peak minus postoperative nadir.
Measured: 30 days post-Liver transplatation
Red blood cell transfusion volume (units)
Units of packed red blood cells transfused within 30 days after LT.
Measured: 30 days post-Liver transplatation
Platelet transfusion volume (bags)
Bags of platelets transfused within 30 days after LT.
Measured: 30 days post-Liver transplatation
Concomitant thrombopoietic agent use
Use of other thrombopoietic agents (e.g., recombinant human thrombopoietin), recorded as binary (yes/no).
Measured: 30 days post-Liver transplatation
Infection (culture-proven + symptoms)
Presence of culture-confirmed infection with accompanying clinical symptoms within 30 days after LT.
Measured: 30 days post-Liver transplatation
Mechanical ventilation requirement
Requirement for postoperative mechanical ventilation support.
Measured: 30 days post-Liver transplatation
Renal replacement therapy requirement
Requirement for postoperative dialysis.
Measured: 30 days post-Liver transplatation
Thrombotic events
Deep vein thrombosis or hepatic artery thrombosis.
Measured: 30 days post-Liver transplatation
30-day mortality
All-cause death within 30 days after liver transplantation.
Measured: 30 days post-Liver transplatation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Nov 2019
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplanatationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600905
- Sponsor's protocol ID
- B2026-303
- Status last verified
- Aug 2026
- First submitted
- 16 May 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Avatrombopag for Severe Post-Transplantation Thrombocytopenia in Liver Transplant Recipients: A Propensity-Score Matched Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07600905
- Acronym / sponsor ID
- B2026-303
- Keywords
- Avatrombopag, Platelet recovery, Liver transplanatation, Severe Thrombocytopenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Avatrombopag Group / Arm 2: Control Group | – | Drug: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who underwent liver transplantation at Zhongshan Hospital, Fudan University between November 2019 and August 2025
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avatrombopag 20 mg Oral Tablet40 mg orally once daily for 5 days, initiated when postoperative platelet count fell below 30×10⁹/L after liver transplatation | Drug | Arm 1: Avatrombopag Group / Arm 2: Control Group |
Primary outcome
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.
9 secondary outcomes
Absolute platelet increase (×10⁹ cells/L)
Time frame: 30 days post-Liver transplatation
Red blood cell transfusion volume (units)
Time frame: 30 days post-Liver transplatation
Platelet transfusion volume (bags)
Time frame: 30 days post-Liver transplatation
Concomitant thrombopoietic agent use
Time frame: 30 days post-Liver transplatation
Infection (culture-proven + symptoms)
Time frame: 30 days post-Liver transplatation
Mechanical ventilation requirement
Time frame: 30 days post-Liver transplatation
Renal replacement therapy requirement
Time frame: 30 days post-Liver transplatation
Thrombotic events
Time frame: 30 days post-Liver transplatation
30-day mortality
Time frame: 30 days post-Liver transplatation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplanatation and Postoperative Complication, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
platelet rise rate (time frame: 30 days post-LT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.