A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03281252

Enrollment

100

Registered

2017-09-13

Start date

2017-04-16

Completion date

2017-09-16

Last updated

2017-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemostatic Disorder, Liver Failure, Acute on Chronic

Keywords

liver failure

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

* 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)

Design outcomes

Primary

Measure	Time frame	Description
28-day progression	28-day	progressed to EASL or APASL defined ACLF or death

Secondary

Measure	Time frame	Description
major bleeding event	90-day	major bleeding event happen
28-day mortality	28-day	death within 28 days

Countries

China

Contacts

Primary ContactJinjun Chen, PHD

chjj@smu.edu.cn0086-18588531001

Backup ContactXutong Yu, Bachelor

nancy2003yu@aliyun.com0086-15602339371

Outcome results