Cirrhosis Clinical Trial
Official title:
Assessment of Coagulation Abnormalities in Acute on Chronic Liver Failure Patients Using Thromboelastography
Patients of acute & chronic liver failure have long been assumed to have coagulopathy & are given blood products prophylactically as well as during various interventions. But these patients rarely have spontaneous bleed except variceal bleed. Conventional coagulation parameters are insufficient to assess coagulation status of these patients because they reflect only a certain element of coagulation cascade while thromboelastography (TEG) gives a comprehensive report of hemostatic profile including platelet function. Studies using TEG have suggested that defects in prohemostatic drivers are counterbalanced by changes in antihemostatic drivers creating a rebalance in these patients. Acute on chronic failure is a entity with acute decompensation on underlying chronic liver failure. Since there is paucity of data regarding coagulation abnormalities in these patient, study is needed to assess predictability power of TEG in these patients with respect to coagulation abnormalities in patient with ALF and CLD ( cirrhosis) and healthy controls.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. All consecutive ALF, ACLF & cirrhotic patients and healthy controls 2. Written informed consent (patient or his nearest relative) Exclusion Criteria: 1. Patients on anti-platelet or anticoagulant therapy 2. Pregnancy and immediate post-partum period 3. History of underlying hypercoagulable/ hypocoagulable states eg. PNH, Polycythemia, Hemophilia 4. Patients with renal failure |
Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
India | Dr. S K Acharya | New Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in r, k and MA- TEG parameters in ACLF | 1 day | No | |
Secondary | Comparison of r, k and MA- TEG parameters with conventional tests of coagulation (i.e PT, aPTT) | 1 day | No | |
Secondary | Development of renal failure, progression of hepatic encephalopathy, variceal bleeding and sepsis in patients with r, k and MA- TEG parameters | 28 days | No | |
Secondary | Death in patients with abnormal r, k and MA- TEG parameters | 28 days | No |
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