Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06066814
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-04
First Post:
2023-09-28
Brief Title:
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
Sponsor:
Institute of Liver and Biliary Sciences India
Organization:
Institute of Liver and Biliary Sciences India
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute on chronic liver failure ACLF is a syndrome characterized by acute decompensation of chronic liver disease associated with organ failures and high short- term mortality Development of systemic inflammation and subsequent organ failures determines is associate with poor outcome and short-term mortality Previous studies have shown that endothelial injury leading to increase in levels of and exhaustion of its cleaving protein a disintegrin and metalloproteinase with a thrombospondin type 1 motif member 13 ADAMTS 13 which promotes the platelet microthrombi formation and subsequent organ ischemia We propose that the vWF ADAMTS 13 ratio can be predict the organ failure development and subsequent mortality in ACLF patients which is considered to be a inflammatory state
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
1 To study efficacy of vWF Ag ADAMTS-13 ratio in predicting 28 days transplant free survival
2 To study efficacy of day 1 and day 4 vWF and ADAMTS 13 level with in predicting development of organ failures at day
3 To efficacy of day 1 and day 4 vWF and ADAMTS 13 level with in predicting 28 days transplant free survival
4 To compare vWF ADAMTS 13 level and vWF Ag ADAMTS-13 ratio across different grades of AARC ACLF
5 To compare vWF ADAMTS 13 level and vWF Ag ADAMTS-13 ratio with AARC MELD SOFA CLIF-ACLF scores
6 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
Ho 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 timeINR D-Dimer Fibrinogen ROTEM arterial lactate Von Willebrand factor antigen ADAMTS 13 activity Organ failure assessment with SOFA score Disease Severity assessment with AARCMELDCLIF-ACLF DAY 4 - Routine investigations Hemogram TLC DLC KFT LFT Prothrombin timeINR D-Dimer Fibrinogen ROTEM arterial lactate Von Willebrand factor antigen ADAMTS 13 activity Organ failure assessment with SOFA score Disease Severity assessment with AARCMELDCLIF-ACLF DAY 7 - Routine investigations Hemogram TLC DLC KFT LFT Prothrombin timeINR D-Dimer Fibrinogen ROTEM arterial lactate Von Willebrand factor antigen ADAMTS 13 activity Organ failure assessment with SOFA score Disease Severity assessment with AARCMELDCLIF-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 failuredysfunction will be assessed by CLF SOFA score
Organ failure will be defined as
Renal failure Creatinine 20 mgdL or RRT Cerebral failure Grade 3-4 Circulatory failure Vasopressor requirement Respiratory failure PaO2FiO2 200 or SpO2FiO2 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 squareFissure 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-value005 will be considered as significant
Adverse effects NA
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
1 To study efficacy of vWF Ag ADAMTS-13 ratio in predicting 28 days transplant free survival
2 To study efficacy of day 1 and day 4 vWF and ADAMTS 13 level with in predicting development of organ failures at day
3 To efficacy of day 1 and day 4 vWF and ADAMTS 13 level with in predicting 28 days transplant free survival
4 To compare vWF ADAMTS 13 level and vWF Ag ADAMTS-13 ratio across different grades of AARC ACLF
5 To compare vWF ADAMTS 13 level and vWF Ag ADAMTS-13 ratio with AARC MELD SOFA CLIF-ACLF scores
6 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
Ho 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 timeINR D-Dimer Fibrinogen ROTEM arterial lactate Von Willebrand factor antigen ADAMTS 13 activity Organ failure assessment with SOFA score Disease Severity assessment with AARCMELDCLIF-ACLF DAY 4 - Routine investigations Hemogram TLC DLC KFT LFT Prothrombin timeINR D-Dimer Fibrinogen ROTEM arterial lactate Von Willebrand factor antigen ADAMTS 13 activity Organ failure assessment with SOFA score Disease Severity assessment with AARCMELDCLIF-ACLF DAY 7 - Routine investigations Hemogram TLC DLC KFT LFT Prothrombin timeINR D-Dimer Fibrinogen ROTEM arterial lactate Von Willebrand factor antigen ADAMTS 13 activity Organ failure assessment with SOFA score Disease Severity assessment with AARCMELDCLIF-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 failuredysfunction will be assessed by CLF SOFA score
Organ failure will be defined as
Renal failure Creatinine 20 mgdL or RRT Cerebral failure Grade 3-4 Circulatory failure Vasopressor requirement Respiratory failure PaO2FiO2 200 or SpO2FiO2 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 squareFissure 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-value005 will be considered as significant
Adverse effects NA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None