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

Primary Purpose

28 Day Mortality

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
plasma exchange
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 28 Day Mortality

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Nanfang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

plasma exchange

standard medical treatment

Arm Description

when ADP inhibition >30%, plasma exchange, once or twice a week, 1000-1500ml plasma was exchanged for each time

standard medical treatment

Outcomes

Primary Outcome Measures

28-day mortality

Secondary Outcome Measures

Full Information

First Posted
February 6, 2021
Last Updated
February 6, 2021
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04747106
Brief Title
Thromboelastography Guides a Multicentre Cluster Controlled Study of Plasma Exchange for Hepatitis B Associated Acute-on-chronic Liver Failure
Official Title
Thromboelastography Guides a Multicentre Cluster Controlled Study of Plasma Exchange for Hepatitis B Associated Acute on Chronic Liver Failure
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
28 Day Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
plasma exchange
Arm Type
Experimental
Arm Description
when ADP inhibition >30%, plasma exchange, once or twice a week, 1000-1500ml plasma was exchanged for each time
Arm Title
standard medical treatment
Arm Type
No Intervention
Arm Description
standard medical treatment
Intervention Type
Biological
Intervention Name(s)
plasma exchange
Intervention Description
when ADP inhibition >30%, plasma exchange, once or twice a week, 1000-1500ml plasma was exchanged for each time
Primary Outcome Measure Information:
Title
28-day mortality
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tang Xiaoting
Phone
15626450944
Email
1169996336@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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