Acute on Chronic Liver Failure Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: 1. Patients on antiplatelet or anticoagulant therapy for at any point of time in last 7 days 2. Pregnant female 3. Patient receiving N-acetyl cysteine (NAC) (interferes with the vWF assay) |
Country | Name | City | State |
---|---|---|---|
India | Institute of Liver & Biliary Sciences. | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients developing of any organ failures by day 7 with increased vWF: ADAMTS 13 ratio | Day 7 | ||
Secondary | Proportion of patients alive by day 28 without transplant with increased vWF: ADAMTS 13 ratio. | Day 28 | ||
Secondary | 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 | ||
Secondary | Proportion of patients alive by day 28 without transplant with increased day 1 and day 4 vWF and ADAMTS 13 level. | Day 28 | ||
Secondary | Proportion of patients with increased vWF, ADAMTS 13 level and vWF Ag : ADAMTS-13 ratio across different grades of AARC ACLF | Day 28 | ||
Secondary | 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 | ||
Secondary | 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. | Day 28 |
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