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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03281252
Other study ID # 001
Secondary ID
Status Recruiting
Phase N/A
First received September 11, 2017
Last updated September 11, 2017
Start date April 16, 2017
Est. completion date September 16, 2017

Study information

Verified date July 2017
Source Nanfang Hospital of Southern Medical University
Contact Jinjun Chen, PHD
Phone 0086-18588531001
Email chjj@smu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 16, 2017
Est. primary completion date September 16, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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)

Study Design


Locations

Country Name City State
China Nanfang Hospital Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 28-day progression progressed to EASL or APASL defined ACLF or death 28-day
Secondary major bleeding event major bleeding event happen 90-day
Secondary 28-day mortality death within 28 days 28-day
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