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

NCT ID: NCT03281252

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-16

Study Completion Date

2017-09-16

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Failure, Acute on Chronic Hemostatic Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nanfang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinjun Chen, PHD

Role: CONTACT

0086-18588531001

Xutong Yu, Bachelor

Role: CONTACT

0086-15602339371

Facility Contacts

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Aishan Su

Role: primary

02064786845

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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