UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036660 |
|---|---|
| Receipt number | 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 19:52:55 |
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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
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
pratapsagartiwari@gmail.com
Public contact
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
pratapsagartiwari@gmail.com
Sponsor or person
Institute
Christian Medical College
Hepatology Department
Vellore, Tamilnadu, India
Zip: 632004
liverresearch@cmcvellore.ac.in
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041760
