Liver Failure, Acute on ChronicNCT03281252
A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China
An observational study of Liver Failure, Acute on Chronic and Hemostatic Disorder, 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. However, the minor and major bleeding events has not been described yet. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Failure, Acute on Chronic, Hemostatic Disorder
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2017to 16 Sep 2017
- 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: pre-acute-on-chronic liver failure and acute-on-chronic liver failure
Who may be able to join
- patient with previously or undiagnosed chronic liver disease/cirrhosis;
- serum bilirubin higher than 3 mg/dl (51 mmol/L) or ALT>10ULN（male 300 U/L; female 200 U/L)
Who cannot join
- those who had or been diagnosed hepatocellular carcinoma or other types of malignancies;
- pregnancy;
- obstructive biliary diseases or other disease lead to bilirubin evaluation;
- using steroid or immunosuppressant in 4 weeks;
- prior surgeries including splenectomy，subtotal splenectomy and disconnection，liver 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)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong, 510515
Aishan Su, 02064786845, nfyyqx@126.com
About this study
Ineffective hemostasis or a paradoxical prothrombotic state of Acute-on-chronic liver disease (ACLF) has been well established. However, the minor and major bleeding events has not been described yet. We observe the patients' major and minor bleeding events and use 4 criteria, which include BARC, ISTH, TIMI, Gusto ,to evaluate the incident rate of bleeding events in ACLF patients and pre-ACLF patients.
- Keywords
- liver failure
- Medical subject headings
- Acute-On-Chronic Liver Failure, Hemostatic Disorders, Liver Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day progression
progressed to EASL or APASL defined ACLF or death
Measured: 28-day
Secondary outcomes (2)
major bleeding event
major bleeding event happen
Measured: 90-day
28-day mortality
death within 28 days
Measured: 28-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start16 Apr 2017
- Primary completion16 Sep 2017 (estimated)
- Study completion16 Sep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Failure, Acute on ChronicStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281252
- Sponsor's protocol ID
- 001
- Status last verified
- Jul 2017
- First submitted
- 11 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China
- ClinicalTrials.gov ID
- NCT03281252
- Acronym / sponsor ID
- 001
- Keywords
- liver failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 16 Apr 2017 (actual)
- Primary completion
- 16 Sep 2017 (estimated)
- Study completion
- 16 Sep 2017 (estimated)
- First posted
- 13 Sep 2017 (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. However, the minor and major bleeding events has not been described yet. We observe the patients' major and minor bleeding events and use 4 criteria, which include BARC, ISTH, TIMI, Gusto ,to evaluate the incident rate of bleeding events in ACLF patients and pre-ACLF patients.
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
- pre-acute-on-chronic liver failure and acute-on-chronic liver failure
Key inclusion criteria (2 listed)
- patient with previously or undiagnosed chronic liver disease/cirrhosis;
- serum bilirubin higher than 3 mg/dl (51 mmol/L) or ALT>10ULN（male 300 U/L; female 200 U/L)
Key exclusion criteria (6 listed)
- those who had or been diagnosed hepatocellular carcinoma or other types of malignancies;
- pregnancy;
- obstructive biliary diseases or other disease lead to bilirubin evaluation;
- using steroid or immunosuppressant in 4 weeks;
- prior surgeries including splenectomy，subtotal splenectomy and disconnection，liver transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day progression
Time frame: 28-day
progressed to EASL or APASL defined ACLF or death
2 secondary outcomes
major bleeding event
Time frame: 90-day
28-day mortality
Time frame: 28-day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2017.
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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.
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 Liver Failure, Acute on Chronic and Hemostatic Disorder, 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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinjun Chen, PHD (0086-18588531001, chjj@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day progression (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 13 Sep 2017.