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.

NCT06066814 | Unknown

• 1 other identifier: ILBS-ACLF-14
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• Proportion of patients developing of any organ failures by day 7 with increased vWF: ADAMTS 13 ratio

  Day 7

Secondary Outcomes (6)

• Proportion of patients alive by day 28 without transplant with increased vWF: ADAMTS 13 ratio.

  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.

  Day 7

• Proportion of patients alive by day 28 without transplant with increased day 1 and day 4 vWF and ADAMTS 13 level.

  Day 28

• Proportion of patients with increased vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio across different grades of AARC ACLF

  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

  Day 28

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients with age \>18 years who are diagnosed having ACLF fulfilling APASL ACLF criteria

You may qualify if:

• \- 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences.

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Dr Tushar Madke, MD

CONTACT

01146300000; drtusharmadke@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 4, 2023
• Study Start: October 7, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-09

Locations

IN (1)