Thromboelastography Guides a Multicentre Cluster Controlled Study of Plasma Exchange for Hepatiti… (NCT04747106) | Clinical Trial Compass
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Thromboelastography Guides a Multicentre Cluster Controlled Study of Plasma Exchange for Hepatitis B Associated Acute-on-chronic Liver Failure
China390 participantsStarted 2020-07-01
Plain-language summary
In the past ten years, the extracorporeal liver support system has been widely used in clinical practice as a first-line treatment of liver failure. Plasma exchange (PE) can remove toxic substances in ACLF patients, reduce liver damage, and replenish coagulation factors, albumin and immunoglobulins, thereby improving the liver's microenvironment and accelerating liver regeneration and functional recovery. The ACLF study showed that PE can improve the symptoms of patients and improve the short-term prognosis of patients, but there are still studies showing that PE does not significantly improve the short-term prognosis of patients. Therefore, the therapeutic effect of PE on ACLF is still controversial. We consider that some people may benefit from plasma exchange, and new indicators are needed to guide disease stratification treatment. Our multi-center prospective data show that plasma exchange has a tendency to improve survival in ACLF-2. After stratifying with ADP inhibition rate in ACLF-2, patients with ADP inhibition rate greater than 30% will be treated 28 days after PE treatment. The prognosis is improving. Therefore, we consider that PE is expected to reduce the mortality of patients with ACLF 2 with an ADP suppression rate greater than 30%, but prospective large-sample clinical studies are still needed.
Who can participate
Age range
16 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\) 18-80 years old; 2) Chronic HBV infection related: HBsAg positive for more than 6 months; 3) EASL-ACLF grade 2
Exclusion Criteria:
* 1\) Other causes of chronic liver disease; 2) Active bleeding and diffuse intravascular coagulation; 3) Those who have been severely allergic to blood products and heparin in the past; 4) Circulatory failure; 5) Respiratory failure; 6) Patients with unstable period of cardiovascular and cerebrovascular infarction; 7) Those who have received platelet transfusion or artificial liver within 1 week; 8) Patients with liver cancer or other malignant tumors; 9) Pregnant and lactating women; 10) Those with other serious chronic diseases; 11) Fail to sign the informed consent form; 12) Circumstances that the researcher considers inappropriate to participate in the research.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
28-day mortality
Timeframe: 28 days
Trial details
NCT IDNCT04747106
SponsorNanfang Hospital, Southern Medical University