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Thromboelastography Guides a Multicentre Cluster Controlled Study of Plasma Exchange for Hepatitis B Associated Acute-on-chronic Liver Failure

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ClinicalTrials.gov Identifier: NCT04747106
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Jinjun Chen, Nanfang Hospital of Southern Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
28 Day Mortality Biological: plasma exchange Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Thromboelastography Guides a Multicentre Cluster Controlled Study of Plasma Exchange for Hepatitis B Associated Acute on Chronic Liver Failure
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: plasma exchange
when ADP inhibition >30%, plasma exchange, once or twice a week, 1000-1500ml plasma was exchanged for each time
Biological: plasma exchange
when ADP inhibition >30%, plasma exchange, once or twice a week, 1000-1500ml plasma was exchanged for each time

No Intervention: standard medical treatment
standard medical treatment



Primary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28 days ]


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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747106


Locations
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China, Guangdong
Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Tang Xiaoting    15626450944    1169996336@qq.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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Responsible Party: Jinjun Chen, Associate Director, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04747106    
Other Study ID Numbers: PE
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Liver Failure
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatic Insufficiency
Liver Failure, Acute