ThrombelastographyNCT04119973
A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China
An observational study of Thrombelastography and Acute on Chronic Liver Failure, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Thrombelastography, Acute on Chronic Liver Failure, Platelet
- What is being tested?
- standard treatment
- How many people
- 486 participants
- Where
- 1 siteChina
- Study dates
- 16 Aug 2018to 4 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ACLF regardless of aetiology, International Normalized Ratio (INR)≥1.5 and total bilirubin≥85μmol/L
Who may be able to join
- INR≥1.5 and total bilirubin≥85μmol/L
Who cannot join
- INR≤1.5 or total bilirubin≤85μmol/L;
- those who had hepatocellular carcinoma or other types of malignancies;
- obstructive biliary diseases or other disease lead to bilirubin evaluation;
- those who had acute hemorrhage one week before admission
- those who received platelet, cryo transfusion or plasmapheresis one week before admission
- pregnancy and breastfeeding
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- those who received liver transplantation or kidney transplantation;
- combine with other disease lead to organ failure including heart failure (NYHA IV),respiratory failure（PaO2<60mmHg),renal insufficiency(CKD 5) and conscious disturbance (GCS<8)
- readmission;
- death within 24 hours.
Trial locations and contacts
1 site in 1 country.
China1 site
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels between plasma components and cellular component of coagulation. And through the platelet mapping, it can help provide a picture of patients' function of platelet. Based on the primary result of our derivation cohort(NCT03281278), ACLF patients with high ADP inhibition rate had high 28-day mortality.This multicenter validation cohort aims to validate the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.
- Conditions
- Thrombelastography, Acute on Chronic Liver Failure, Platelet, Multicenter Prospective Study
- Being tested
- standard treatment
- Keywords
- Thrombelastography, Acute on Chronic Liver Failure, Platelet, Multicenter Prospective Study
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard treatmentOther
standard medical treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
death within 28-day
Measured: 28-day
Secondary outcomes (2)
28-day progression
progressed to EASL defined ACLF
Measured: 28-day
90-day mortality
death within 90-day
Measured: 90-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start16 Aug 2018
- Primary completion4 Aug 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombelastographyStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Southwest Hospital, China, The First Hospital of Jilin University, First Affiliated Hospital of Xinjiang Medical University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Xiangya Hospital of Central South University, Taihe Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119973
- Sponsor's protocol ID
- 009
- Status last verified
- May 2019
- First submitted
- 7 Oct 2019
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Study of Application of Platelet Mapping in Acute-on-chronic-liver Failure in China
- ClinicalTrials.gov ID
- NCT04119973
- Acronym / sponsor ID
- 009
- Conditions
- Thrombelastography, Acute on Chronic Liver Failure, Platelet, Multicenter Prospective Study
- Keywords
- Thrombelastography, Acute on Chronic Liver Failure, Platelet, Multicenter Prospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Southwest Hospital, China, The First Hospital of Jilin University, First Affiliated Hospital of Xinjiang Medical University, Meng Chao Hepatobiliary Hospital of Fujian Medical University, Xiangya Hospital of Central South University, Taihe Hospital
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 4 Aug 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. Thrombelastography measures the dynamics of thrombin production and provides a global assessment of coagulation incorporating the cumulative effect of the interactions at various levels between plasma components and cellular component of coagulation. And through the platelet mapping, it can help provide a picture of patients' function of platelet. Based on the primary result of our derivation cohort(NCT03281278), ACLF patients with high ADP inhibition rate had high 28-day mortality.This multicenter validation cohort aims to validate the predictive role of platelet mapping in ACLF prognosis, organ failure developments and short term mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ACLF regardless of aetiology, International Normalized Ratio (INR)≥1.5 and total bilirubin≥85μmol/L
Key inclusion criteria (1 listed)
- INR≥1.5 and total bilirubin≥85μmol/L
Key exclusion criteria (10 listed)
- INR≤1.5 or total bilirubin≤85μmol/L;
- those who had hepatocellular carcinoma or other types of malignancies;
- obstructive biliary diseases or other disease lead to bilirubin evaluation;
- those who had acute hemorrhage one week before admission
- those who received platelet, cryo transfusion or plasmapheresis one week before admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard treatmentstandard medical treatment | Other | – |
Primary outcome
28-day mortality
Time frame: 28-day
death within 28-day
2 secondary outcomes
28-day progression
Time frame: 28-day
90-day mortality
Time frame: 90-day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombelastography and Acute on Chronic Liver Failure, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.