NCT03281252

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2017

Completed
Last Updated

September 13, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

September 11, 2017

Last Update Submit

September 11, 2017

Conditions

Liver Failure, Acute on ChronicHemostatic Disorder

Keywords

liver failure

Outcome Measures

Primary Outcomes (1)

  • 28-day progression

    progressed to EASL or APASL defined ACLF or death

    28-day

Secondary Outcomes (2)

  • major bleeding event

    90-day

  • 28-day mortality

    28-day

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pre-acute-on-chronic liver failure and acute-on-chronic liver failure

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver FailureHemostatic DisordersLiver Failure

Condition Hierarchy (Ancestors)

Liver Failure, AcuteHepatic InsufficiencyLiver DiseasesDigestive System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Jinjun Chen, PHD

CONTACT

0086-18588531001chjj@smu.edu.cn

Xutong Yu, Bachelor

CONTACT

0086-15602339371nancy2003yu@aliyun.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

April 16, 2017

Primary Completion

September 16, 2017

Study Completion

September 16, 2017

Last Updated

September 13, 2017

Record last verified: 2017-07

Locations

CN(1)