- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06066814
To Study the Role of Plasma Von Willebrand Factor Antigen (vWF) to A Disintegrin-like and Metalloproteinase With Thrombospondin Type-1 Motifs 13 (ADAMTS-13) Activity Ratio as a Predictor of Development of Extrahepatic Organ Failure in Acute on Chronic Liver Failure (ACLF) Patients.
To Study the Role of Plasma Von Willebrand Factor Antigen (vWF) to A Disintegrin-like and Metalloproteinase With Thrombospondin Type-1 Motifs 13 (ADAMTS-13) Activity Ratio as a Predictor of Development of Extrahepatic Organ Failure in Acute on Chronic Liver Failure (ACLF) Patients
Study Overview
Status
Conditions
Detailed Description
Null Hypothesis:
Systemic inflammation in acute-on-chronic liver failure (ACLF) leads to endothelial injury leading to increased vWF levels and exhaustion of its cleaving protein ADAMTS 13 which promotes the platelet microthrombi formation, leading to subsequent organ failures which are the strong predictors of short term mortality.
AIM: - To evaluate the role of plasma Von Willebrand factor antigen to ADAMTS-13 activity ratio in predicting organ failure in acute on chronic liver failure (ACLF) patients Objective -
Primary objective:
To study efficacy of Von Willebrand factor antigen to ADAMTS-13 activity ratio in predicting development of organ failures at day 7
Secondary objectives:
- To study efficacy of vWF Ag : ADAMTS-13 ratio in predicting 28 days transplant free survival.
- To study efficacy of day 1 and day 4 vWF and ADAMTS 13 level with in predicting development of organ failures at day.
- To efficacy of day 1 and day 4 vWF and ADAMTS 13 level with in predicting 28 days transplant free survival.
- To compare vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio across different grades of AARC ACLF.
- To compare vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio with AARC, MELD, SOFA, CLIF-ACLF scores.
- To compare the impact of different therapies on vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio (PLEX, Etiology specific : steroids, antivirals).
Study population: All the patients with age >18 years who are diagnosed having ACLF fulfilling APASL ACLF criteria Study design: Prospective cohort study Study period: September 2023 - December 2023 Intervention: This is a prospective cohort study and will be conducted at ILBS New Delhi
The following data will be recorded for each patient:
H/o of jaundice, distension abdomen, swelling feet, altered sensorium, vomiting of blood or passing melena Acute and chronic etiology of ACLF Clinical examination: Ascites with grade, glass glow coma scale, west heaven hepatic encephalopathy grade, heart rate, blood pressure, urine output Height, weight and BMI Day 0 - Routine investigations: Hemogram, TLC, DLC, KFT, LFT, Prothrombin time/INR D-Dimer, Fibrinogen, ROTEM, arterial lactate Von Willebrand factor antigen, ADAMTS 13 activity Organ failure assessment with SOFA score Disease Severity assessment with AARC/MELD/CLIF-ACLF DAY 4 - Routine investigations: Hemogram, TLC, DLC, KFT, LFT, Prothrombin time/INR D-Dimer, Fibrinogen, ROTEM, arterial lactate Von Willebrand factor antigen, ADAMTS 13 activity Organ failure assessment with SOFA score Disease Severity assessment with AARC/MELD/CLIF-ACLF DAY 7: - Routine investigations: Hemogram, TLC, DLC, KFT, LFT, Prothrombin time/INR D-Dimer, Fibrinogen, ROTEM, arterial lactate Von Willebrand factor antigen, ADAMTS 13 activity Organ failure assessment with SOFA score Disease Severity assessment with AARC/MELD/CLIF-ACLF Day 28- Final outcome assessment death or alive Total five organs parameters will be assessed: Kidney, Brain, Coagulation, Circulatory, Respiratory
Liver failure will be assessed by AARC score:
Extrahepatic organ failure/dysfunction will be assessed by CLF SOFA score
Organ failure will be defined as:
Renal failure: Creatinine >2.0 mg/dL or RRT Cerebral failure: Grade 3-4 Circulatory failure: Vasopressor requirement Respiratory failure: PaO2/FiO2 <200 or SpO2/FiO2 <214 Monitoring and assessment: All the parameters of the objective and also noted any adverse effects.
STATISTICAL ANALYSIS:
The data will be entered in Microsoft excel and will be analyzed using SPSS version 22. The categorical data will be analysed using Chi square/Fissure test. Exact test and continuous data will be compiled using t-test. Besides this the univariate and multivariate survival analysis will be carried out using Cox regression method. Kaplan-Meier technique will be applied for further analysis. P-value<0.05 will be considered as significant.
Adverse effects: NA
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Dr Tushar Madke, MD
- Phone Number: 01146300000
- Email: drtusharmadke@gmail.com
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Institute of Liver & Biliary Sciences.
-
Contact:
- Dr Tushar Madke, MD
- Phone Number: +91-011-46300000
- Email: drtusharmadke@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All the patients with age >18 years who are diagnosed having ACLF fulfilling APASL ACLF criteria and do not have any extrahepatic organ failure at enrollment.
Exclusion Criteria:
- Patients on antiplatelet or anticoagulant therapy for at any point of time in last 7 days
- Pregnant female
- Patient receiving N-acetyl cysteine (NAC) (interferes with the vWF assay)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients developing of any organ failures by day 7 with increased vWF: ADAMTS 13 ratio
Time Frame: Day 7
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients alive by day 28 without transplant with increased vWF: ADAMTS 13 ratio.
Time Frame: Day 28
|
Day 28
|
Proportion of patients developing of any organ failures by day 7 with increased day 1 and day 4 vWF and ADAMTS 13 level.
Time Frame: Day 7
|
Day 7
|
Proportion of patients alive by day 28 without transplant with increased day 1 and day 4 vWF and ADAMTS 13 level.
Time Frame: Day 28
|
Day 28
|
Proportion of patients with increased vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio across different grades of AARC ACLF
Time Frame: Day 28
|
Day 28
|
Proportion of patients having change in vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio compared to change in AARC, MELD, CLIF-ACLF scores
Time Frame: Day 28
|
Day 28
|
Proportion of patients having change in vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio at day 7 different therapies (Nutrition, Plasma exchange, Prednisolone, Nucleos(t)ide analogue in hepatitis B) on vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio.
Time Frame: Day 28
|
Day 28
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-ACLF-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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