Acute-On-Chronic Liver FailureNCT04564651
Platelet Transfusion in Acute-on Chronic Liver Failure
A study testing platelet transfusion in people with Acute-On-Chronic Liver Failure, run by Nanfang Hospital, Southern Medical University at 8 sites in China.
Trial summary
Acute on-chronic liver failure (ACLF) is a severe liver disease with a 28-day mortality rate of up to 40%. When the patients get 3 or more organ failures, the 28-day mortality rate is up to 82.6%. Though the ACLF patients have high short-term mortality, and the only effective treatment method is liver transplantation. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- platelet transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 8 sitesChina
- Study dates
- 1 May 2019to 1 May 2024
- Phase
- Interventional
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 18-60 years old;
- Patients with compensated cirrhosis conformed to the (ACLF) diagnostic criteria of chronic and acute liver failure defined by the European Association of Hepatology (EASL-CLIF), and met the ACLF-2 and 3 grades.
- ADP inhibition rate ≥ 70%.
Who cannot join
- Patients with severe platelet allergy in the past;
- Coma caused by cerebral hemorrhage or primary diseases of the nervous system;
- Those who have taken anti-platelet drugs or anticoagulants within four weeks;
- Rupture and bleeding of EVB occurred within 1 week.
- Those who received platelet transfusion within 1 week;
- Patients with liver cancer or other malignant tumors;
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- Pregnant and lactating women;
- Complicated with other serious chronic diseases;
- Not signing the informed consent form;
- Other researchers do not consider it appropriate to participate in the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
The First Affiliated Hospital of Jilin University
Changchun, Jilin
Pujun Gao
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Yan Huang
- Recruiting
The First Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality
Jie Xia
- Recruiting
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Fujian
Zuxiong Huang
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Jinjun Chen, +8615521287260, chjj@smu.edu.cn
Tingting Qi, +8615521287260, tingtingqi@126.com
- Recruiting
Shanghai Public Health Clinical Center
Shanghai
Zhiping Qian
- Recruiting
Taihe Hospital affiliated to Hubei Medical College
Shiyan, Hubei
Zhongji Meng
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, Xinjiang
Xiaobo Lu
About this study
Acute on-chronic liver failure (ACLF) is a severe liver disease with a 28-day mortality rate of up to 40%. When the patients get 3 or more organ failures, the 28-day mortality rate is up to 82.6%. Though the ACLF patients have high short-term mortality, and the only effective treatment method is liver transplantation. However, few patients can be treated due to the scarcity of liver source, rapid disease progression and short transplantation window.
Our team evaluated the platelet function of 100 patients with ACLF by using the thromboelastograghy (TEG 5000). It was found for the first time that the reactivity of platelets of ACLF patients decreased, and the platelet inhibition rate (especially the ADP pathway) was related to patients'short-term prognosis. When the ADP inhibition rate was 70%, the patients'28-day mortality was up to 100%. However, the mechanism of low platelet response to ADP in ACLF patients is still unclear. We found that the platelet function in patients with ACLF 2-3 grade and inhibition rate beyond 70% was improved and the 28-day mortality decreased after platelet transfusion. Whether platelet transfusion can prolong survival time needs to be determined in a prospective controlled study. Therefore, this study is expected to find a new therapeutic method to reduce the mortality of patients with ACLF.
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- platelet transfusion
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet transfusionOther
when the ADP inhibition >70%, give one unit platelet tansfusion
| Study group | Role | What they receive |
|---|---|---|
| platelet transfusion treatment | Experimental | Not described Receives: Other: platelet transfusion |
| standard medical treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day transplant-free mortality
whether participant died or not without liver transplantation
Measured: 28 days
Secondary outcomes (1)
90-day transplant-free mortality
mortality without transplant in 90 day
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start1 May 2019
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinjun Chen, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564651
- Sponsor's protocol ID
- 013
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 25 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Transfusion in Acute-on Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT04564651
- Acronym / sponsor ID
- 013
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 25 Sep 2020 (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.
Acute on-chronic liver failure (ACLF) is a severe liver disease with a 28-day mortality rate of up to 40%. When the patients get 3 or more organ failures, the 28-day mortality rate is up to 82.6%. Though the ACLF patients have high short-term mortality, and the only effective treatment method is liver transplantation. However, few patients can be treated due to the scarcity of liver source, rapid disease progression and short transplantation window.
Our team evaluated the platelet function of 100 patients with ACLF by using the thromboelastograghy (TEG 5000). It was found for the first time that the reactivity of platelets of ACLF patients decreased, and the platelet inhibition rate (especially the ADP pathway) was related to patients'short-term prognosis. When the ADP inhibition rate was 70%, the patients'28-day mortality was up to 100%. However, the mechanism of low platelet response to ADP in ACLF patients is still unclear. We found that the platelet function in patients with ACLF 2-3 grade and inhibition rate beyond 70% was improved and the 28-day mortality decreased after platelet transfusion. Whether platelet transfusion can prolong survival time needs to be determined in a prospective controlled study. Therefore, this study is expected to find a new therapeutic method to reduce the mortality of patients with ACLF.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| platelet transfusion treatment | Experimental | Other: platelet transfusion |
| standard medical treatment | No intervention | – |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 18-60 years old;
- Patients with compensated cirrhosis conformed to the (ACLF) diagnostic criteria of chronic and acute liver failure defined by the European Association of Hepatology (EASL-CLIF), and met the ACLF-2 and 3 grades.
- ADP inhibition rate ≥ 70%.
Key exclusion criteria (10 listed)
- Patients with severe platelet allergy in the past;
- Coma caused by cerebral hemorrhage or primary diseases of the nervous system;
- Those who have taken anti-platelet drugs or anticoagulants within four weeks;
- Rupture and bleeding of EVB occurred within 1 week.
- Those who received platelet transfusion within 1 week;
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 |
|---|---|---|
| platelet transfusionwhen the ADP inhibition >70%, give one unit platelet tansfusion | Other | platelet transfusion treatment |
Primary outcome
28-day transplant-free mortality
Time frame: 28 days
whether participant died or not without liver transplantation
1 secondary outcome
90-day transplant-free mortality
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Individual participant dataSharing planned: No
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet transfusion in people with Acute-On-Chronic Liver Failure, run by Nanfang Hospital, Southern Medical University at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Jinjun (+8618588531001, chjj@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day transplant-free mortality (time frame: 28 days). 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 25 Sep 2020; AzTrials last refreshed its copy on 4 Nov 2026.