Clinical Trial: Assessment of Coagulation Abnormalities in Acute on Chronic Liver Failure Patients Using Thromboelastography
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Assessment of Coagulation Abnormalities in Acute on Chronic Liver Failure Patients Using Thromboelastography
Brief Summary: 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.
Detailed Summary:
Since early times coagulopathy is considered to be an integral part of liver failure. Whether it is acute liver failure (ALF) or acute on chronic liver failure (ACLF), patients usually have deranged coagulation parameters (platelet count, prothrombin time (PT), activated partial thromboplastin time (aPTT) and international normalized ratio (INR). Based on these deranged parameters, initially it was assumed that patients of liver failure have increased risk of bleeding & usually were given blood products prophylactically during surgical interventions. But these patients of liver failure (acute or chronic) seldom develop spontaneous bleeding, apart from variceal bleeding in chronic liver failure which generally occurs because of portal hypertension. Moreover during invasive procedures also they do not have significant bleeding.
Concept of rebalanced hemostasis has been proposed to explain discrepancy between results of these coagulation parameters & clinical scenario of patients. Normal hemostasis consists of 3 steps: platelet endothelial interaction, coagulation & fibrinolysis. First step is considered to be defective in liver failure because of thrombocytopenia & qualitative platelet dysfunction. However because of decreased plasma concentration of ADAMTS 13, plasma levels of vwF are increased thus increasing stickiness of platelets & rebalancing the primary hemostasis.
Because of deranged INR, it is thought that coagulation cascade is deranged but Tripodi et al have shown that cirrhotics also can generate same amount of thrombin as healthy subjects. All procoagulants (factor II, V, VII, IX, X, XI) & anticoagulant factors (protein C, protein S & antithrombin) except factor VIII are synthesized in liver. Decreased procoagulant activity has been found to be counterbalanced by decreased anticoagula
Sponsor: All India Institute of Medical Sciences, New Delhi
Current Primary Outcome: Changes in r, k and MA- TEG parameters in ACLF [ Time Frame: 1 day ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Comparison of r, k and MA- TEG parameters with conventional tests of coagulation (i.e PT, aPTT) [ Time Frame: 1 day ]
- Development of renal failure, progression of hepatic encephalopathy, variceal bleeding and sepsis in patients with r, k and MA- TEG parameters [ Time Frame: 28 days ]
- Death in patients with abnormal r, k and MA- TEG parameters [ Time Frame: 28 days ]
Original Secondary Outcome: Same as current
Information By: All India Institute of Medical Sciences, New Delhi
Dates:
Date Received: April 25, 2016
Date Started: July 2015
Date Completion: July 2016
Last Updated: April 27, 2016
Last Verified: April 2016
