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

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ClinicalTrials.gov Identifier: NCT03281252
Recruitment Status : Unknown
Verified July 2017 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Study Description
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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.

Condition or disease
Liver Failure, Acute on Chronic Hemostatic Disorder

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Evaluation of Minor Bleeding and Utility of Bleeding Criteria in Acute-on-chronic Liver Failure Patients in China
Actual Study Start Date : April 16, 2017
Estimated Primary Completion Date : September 16, 2017
Estimated Study Completion Date : September 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 28-day progression [ Time Frame: 28-day ]
    progressed to EASL or APASL defined ACLF or death


Secondary Outcome Measures :
  1. major bleeding event [ Time Frame: 90-day ]
    major bleeding event happen

  2. 28-day mortality [ Time Frame: 28-day ]
    death within 28 days


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pre-acute-on-chronic liver failure and acute-on-chronic liver failure
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281252


Contacts
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Contact: Jinjun Chen, PHD 0086-18588531001 chjj@smu.edu.cn
Contact: Xutong Yu, Bachelor 0086-15602339371 nancy2003yu@aliyun.com

Locations
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China, Guangdong
Nanfang Hospital Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Aishan Su    02064786845    nfyyqx@126.com   
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
More Information
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03281252    
Other Study ID Numbers: 001
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nanfang Hospital of Southern Medical University:
liver failure
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Failure, Acute
Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhage
 Pathologic Processes
Liver Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases