UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036660
Receipt No. R000041760
Scientific Title Plasma Von Willebrand factor (vWF) assay compared to Prothrombin time (PT/INR), aPTT and Platelets as predictor of outcome in Alcoholic-Acute-on-chronic-liver failure (A-ACLF)
Date of disclosure of the study information 2019/05/07
Last modified on 2019/05/06 (Ver. 1)

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Basic information
Public title Plasma Von Willebrand factor (vWF) assay compared to Prothrombin time (PT/INR), aPTT and Platelets as predictor of outcome in Alcoholic-Acute-on-chronic-liver failure (A-ACLF)
Acronym Plasma Von Willebrand factor (vWF) assay compared to Prothrombin time (PT/INR), aPTT and Platelets as predictor of outcome in Alcoholic-Acute-on-chronic-liver failure (A-ACLF)
Scientific Title Plasma Von Willebrand factor (vWF) assay compared to Prothrombin time (PT/INR), aPTT and Platelets as predictor of outcome in Alcoholic-Acute-on-chronic-liver failure (A-ACLF)
Scientific Title:Acronym Plasma Von Willebrand factor (vWF) assay compared to Prothrombin time (PT/INR), aPTT and Platelets as predictor of outcome in Alcoholic-Acute-on-chronic-liver failure (A-ACLF)
Region
Asia(except Japan)

Condition
Condition Acute on Chronic Liver failure
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 a) To establish von Willebrand factor (vWf) assay as predictor of inhospital outcome in patients with Alcoholic ACLF.
Basic objectives2 Others
Basic objectives -Others b) Compare the predicting ability of vWf to other pre-existing markers of liver disease severity and other coagulation parameters.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To establish von Willebrand factor (vWf) assay as predictor of inhospital outcome in patients with Alcoholic ACLF.
Key secondary outcomes Compare the predicting ability of vWf to other pre-existing markers of liver disease severity and other coagulation parameters.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Retrospective data of patients who presented as Alcohol related Acute on Chronic Liver Failure admitted in hepatology department were taken for this study.
Key exclusion criteria Patients with hepatocellular carcinoma or portal vein thrombosis and those unwilling to participate were excluded from this study. Pregnant women and children were also excluded.
Target sample size 35

Research contact person
Last name of lead principal investigator
1st name Pratap
Middle name Sagar
Last name Tiwari
Organization Christian Medical College
Division name Hepatology
Zip code 632004
Address Vellore, Tamilnadu, India
TEL 91-9152160634
Email pratapsagartiwari@gmail.com

Public contact
1st name of contact person
1st name Pratap
Middle name Sagar
Last name Tiwari
Organization Christian Medical College
Division name Hepatology
Zip code 632004
Address Vellore, Tamilnadu, India
TEL 91-9152160634
Homepage URL
Email pratapsagartiwari@gmail.com

Sponsor
Institute Christian Medical College
Hepatology Department
Vellore, Tamilnadu, India
Zip: 632004
liverresearch@cmcvellore.ac.in
Institute
Department

Funding Source
Organization Christian Medical College
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization India

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Christian Medical College
Address Institutional Review Board (IRB), Christian Medical College, Office of Research, I st Floor, Carman Block, Bagayam, Vellore 632 002 India.
Tel 0416 -2284294
Email research@cmcvellore.ac.in

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Christian Medical College(India)

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 35
Results 
vWF levels are markedly elevated, correlate with organ failure, and predict in-hospital survival in Alcoholic-ACLF patients. vWF assays (vWF-Ag & vWF-CBA) as predictor of composite poor outcome was comparable to other severity score like MELD and was superior to PT/INR, aPTT and Platelets.
Results date posted
2019 Year 05 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 10 Month 05 Day
Date of IRB
2018 Year 11 Month 02 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2019 Year 01 Month 15 Day
Date of closure to data entry
2019 Year 01 Month 16 Day
Date trial data considered complete
2019 Year 01 Month 20 Day
Date analysis concluded
2019 Year 01 Month 30 Day

Other
Other related information Retrospective data (from October 2014 to march 2015) of patients who presented as Alcohol related ACLF admitted in hepatology department were taken for this study.
All patients day 1 vWF- Antigen and VWF- CBA were noted .
Outcome was noted and categorized in 2 groups ie Discharged alive (Group1) and Composite poor outcome (Group2) that includes death/discharge in terminal condition.

Management information
Registered date
2019 Year 05 Month 06 Day
Last modified on
2019 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041760