Acute on Chronic Liver FailureNCT06066814
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.
An observational study of Acute on Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute on Chronic Liver Failure
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 7 Oct 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients with age >18 years who are diagnosed having ACLF fulfilling APASL ACLF criteria
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences.
New Delhi, National Capital Territory of Delhi, 110070
Dr Tushar Madke, MD, +91-011-46300000, drtusharmadke@gmail.com
About this study
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
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.
Read the 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
- Conditions
- Acute on Chronic Liver Failure
- Medical subject headings
- Acute-On-Chronic Liver Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients developing of any organ failures by day 7 with increased vWF: ADAMTS 13 ratio
Measured: Day 7
Secondary outcomes (6)
Proportion of patients alive by day 28 without transplant with increased vWF: ADAMTS 13 ratio.
Measured: 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.
Measured: Day 7
Proportion of patients alive by day 28 without transplant with increased day 1 and day 4 vWF and ADAMTS 13 level.
Measured: Day 28
Proportion of patients with increased vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio across different grades of AARC ACLF
Measured: 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
Measured: 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.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start7 Oct 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute on Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066814
- Sponsor's protocol ID
- ILBS-ACLF-14
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06066814
- Acronym / sponsor ID
- ILBS-ACLF-14
- Conditions
- Acute on Chronic Liver Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 7 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients with age >18 years who are diagnosed having ACLF fulfilling APASL ACLF criteria
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients developing of any organ failures by day 7 with increased vWF: ADAMTS 13 ratio
Time frame: Day 7
6 secondary outcomes
Proportion of patients alive by day 28 without transplant with increased vWF: ADAMTS 13 ratio.
Time frame: 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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute on Chronic Liver Failure, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Tushar Madke, MD (01146300000, drtusharmadke@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients developing of any organ failures by day 7 with increased vWF: ADAMTS 13 ratio (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.