Acute-On-Chronic Liver FailureNCT03713489
Platelet Transfusion in HBV-related acute-on Chronic Liver Failure
A study testing platelet in people with Acute-On-Chronic Liver Failure, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Acute-on-chronic liver failure (ACLF) is a syndrome that has recently been recognized as encompassing acute deterioration of liver function in patients with pre-existing chronic liver disease. It is associated with multi-organ failure and a high risk of short-term mortality. Thrombocytopenia is common in ACLF. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- What is being tested?
- platelet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Sep 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years old
- Diagnosed with acute-on-chronic liver failure (grade-2) according to EASL-CLIF criteria and grading system.
- Chronic hepatitis B infection.
- ADP inhibition rate ≥70%.
Who cannot join
- Combined with chronic liver disease other than chronic HBV infection.
- Previous decompensation.
- Intracranial hemorrhage proved by radiological methods, symptoms and physical signs.
- Under anti-platelet or anticoagulants therapy within 4 weeks.
- Esophageal variceal bleeding within 1 week.
- Platelets transfusion within 1 week.
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- Hepatocellular carcinoma or other types of malignancies.
- Pregnancy or breastfeeding.
- Severe chronic extra-hepatic disease.
- Comined with situations that researchers considered not suitable for inclusion
- Refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Jinjun Chen, 86-18588531001, chjj@smu.edu.cn
Tingting Qi, +8615521287260, tingtingqi@126.com
About this study
Official title: Platelet Transfusion in HBV-related acute-on Chronic Liver Failure: a Randomized Controlled Study
Acute-on-chronic liver failure (ACLF) is a syndrome that has recently been recognized as encompassing acute deterioration of liver function in patients with pre-existing chronic liver disease. It is associated with multi-organ failure and a high risk of short-term mortality. Thrombocytopenia is common in ACLF. In addition, the function of platelet is also compromised according to our previous data. The aim of this study is to explore whether platelet transfusion could reduce the short-term mortality rate of HBV-related ACLF. This is a single center, open labeled randomized controlled study. There are two arms. Subjects who is assigned to platelet transfusion group will receive both platelet transfusion (9 times/4 weeks, 1 unit each time) and standard medical treatment. While those in standard medical treatment group will receive standard medical treatment only. The major endpoint is 28-day transplant-free mortality rate.
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- platelet
- Keywords
- acute-on-chronic liver failure, platelet, Hepatitis B
- Medical subject headings
- Acute-On-Chronic Liver Failure, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plateletProcedure or surgery
Participants in platelet transfusion group will receive one unit of apheresis platelets transfusion 3 times for the first week after enrollment, then 2 times a week in the following three weeks.
| Study group | Role | What they receive |
|---|---|---|
| Platelet transfusion group | Experimental | Besides standard medical treatment, up to 9 units of platelets will be transfused per protocol within 4 weeks Receives: Procedure: platelet |
| standard medical treatment group | No intervention | standard medical treatment |
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)
transplant-free survival time
survival time without transplation
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 posted19 Oct 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2019 (estimated)
- Study completion30 Sep 2019 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT03713489
- Sponsor's protocol ID
- 008
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- 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 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Transfusion in HBV-related acute-on Chronic Liver Failure: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03713489
- Acronym / sponsor ID
- 008
- Conditions
- Acute-On-Chronic Liver Failure
- Keywords
- acute-on-chronic liver failure, platelet, Hepatitis B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 30 Sep 2019 (estimated)
- First posted
- 19 Oct 2018 (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 syndrome that has recently been recognized as encompassing acute deterioration of liver function in patients with pre-existing chronic liver disease. It is associated with multi-organ failure and a high risk of short-term mortality. Thrombocytopenia is common in ACLF. In addition, the function of platelet is also compromised according to our previous data. The aim of this study is to explore whether platelet transfusion could reduce the short-term mortality rate of HBV-related ACLF. This is a single center, open labeled randomized controlled study. There are two arms. Subjects who is assigned to platelet transfusion group will receive both platelet transfusion (9 times/4 weeks, 1 unit each time) and standard medical treatment. While those in standard medical treatment group will receive standard medical treatment only. The major endpoint is 28-day transplant-free mortality rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet transfusion group | Experimental | Procedure: plateletBesides standard medical treatment, up to 9 units of platelets will be transfused per protocol within 4 weeks |
| standard medical treatment group | No intervention | –standard medical treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years old
- Diagnosed with acute-on-chronic liver failure (grade-2) according to EASL-CLIF criteria and grading system.
- Chronic hepatitis B infection.
- ADP inhibition rate ≥70%.
Key exclusion criteria (11 listed)
- Combined with chronic liver disease other than chronic HBV infection.
- Previous decompensation.
- Intracranial hemorrhage proved by radiological methods, symptoms and physical signs.
- Under anti-platelet or anticoagulants therapy within 4 weeks.
- Esophageal variceal bleeding 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 |
|---|---|---|
| plateletParticipants in platelet transfusion group will receive one unit of apheresis platelets transfusion 3 times for the first week after enrollment, then 2 times a week in the following three weeks. | Procedure or surgery | Platelet transfusion group |
Primary outcome
28-day transplant-free mortality
Time frame: 28 days
whether participant died or not without liver transplantation
1 secondary outcome
transplant-free survival time
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 22 Oct 2018.
- Individual participant dataSharing planned: No
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A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet in people with Acute-On-Chronic Liver Failure, run by Nanfang Hospital, Southern Medical University 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?
The sponsor lists 4 inclusion and 11 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 22 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinjun Chen (+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 22 Oct 2018.