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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04747106

Collaborator

(none)

390

Enrollment

Location

Arms

Anticipated Duration (Months)

39.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Jul 1, 2020

Anticipated Primary Completion Date :

Apr 30, 2021

Anticipated Study Completion Date :

Apr 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

28-day mortality [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nanfang Hospital	Guangzhou	Guangdong	China	510515

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jinjun Chen, Associate Director, Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT04747106

Other Study ID Numbers:

First Posted:

Feb 10, 2021

Last Update Posted:

Feb 10, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis B

Liver Failure

End Stage Liver Disease

Acute-On-Chronic Liver Failure

Study Results

No Results Posted as of Feb 10, 2021