Platelet Transfusion in Acute-on Chronic Liver Failure

September 21, 2020 updated by: Jinjun Chen, Nanfang Hospital of Southern Medical University

Acute on-chronic liver failure (ACLF) is a severe liver disease with a 28-day mortality rate of up to 40%. When the patients get 3 or more organ failures, the 28-day mortality rate is up to 82.6%. Though the ACLF patients have high short-term mortality, and the only effective treatment method is liver transplantation. However, few patients can be treated due to the scarcity of liver source, rapid disease progression and short transplantation window.

Our team evaluated the platelet function of 100 patients with ACLF by using the thromboelastograghy (TEG 5000). It was found for the first time that the reactivity of platelets of ACLF patients decreased, and the platelet inhibition rate (especially the ADP pathway) was related to patients'short-term prognosis. When the ADP inhibition rate was 70%, the patients'28-day mortality was up to 100%. However, the mechanism of low platelet response to ADP in ACLF patients is still unclear. We found that the platelet function in patients with ACLF 2-3 grade and inhibition rate beyond 70% was improved and the 28-day mortality decreased after platelet transfusion. Whether platelet transfusion can prolong survival time needs to be determined in a prospective controlled study. Therefore, this study is expected to find a new therapeutic method to reduce the mortality of patients with ACLF.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Fujian, China
        • Recruiting
        • Meng Chao Hepatobiliary Hospital of Fujian Medical University
        • Contact:
          • Zuxiong Huang
      • Shanghai, China
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
          • Zhiping Qian
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Army Medical University
        • Contact:
          • Jie Xia
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital
    • Hubei
      • Shiyan, Hubei, China
        • Recruiting
        • Taihe Hospital affiliated to Hubei Medical College
        • Contact:
          • zhongji meng
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital Central South University
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The first Affiliated Hospital of Jilin University
        • Contact:
          • Pujun Gao
    • Xinjiang
      • Xinjiang, Xinjiang, China
        • Recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
          • Xiaobo Lu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-60 years old;
  • Patients with compensated cirrhosis conformed to the (ACLF) diagnostic criteria of chronic and acute liver failure defined by the European Association of Hepatology (EASL-CLIF), and met the ACLF-2 and 3 grades.

ADP inhibition rate ≥ 70%.

Exclusion Criteria:

  • Patients with severe platelet allergy in the past;
  • Coma caused by cerebral hemorrhage or primary diseases of the nervous system;
  • Those who have taken anti-platelet drugs or anticoagulants within four weeks;
  • Rupture and bleeding of EVB occurred within 1 week.
  • Those who received platelet transfusion within 1 week;
  • Patients with liver cancer or other malignant tumors;
  • Pregnant and lactating women;
  • Complicated with other serious chronic diseases;
  • Not signing the informed consent form;
  • Other researchers do not consider it appropriate to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: platelet transfusion treatment
Other: platelet transfusion
when the ADP inhibition >70%, give one unit platelet tansfusion
NO_INTERVENTION: standard medical treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
28-day transplant-free mortality
Time Frame: 28 days
whether participant died or not without liver transplantation
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
90-day transplant-free mortality
Time Frame: 90 days
mortality without transplant in 90 day
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital of Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 013 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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