Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy — GOODHEART-ACLF  

Cirrhosis, Liver Clinical Trial

Official title: Thromboelastometry Guided Transfusion Protocol Versus Standard Care in Acute-on-Chronic Liver Failure With Bleeding: A Prospective Intervention Trial

Status Recruiting

Clinical Trial Summary

In this project, we plan to evaluate whether a new, rotational thromboelastometry-guided algorithm (ROTEM) to guide hemostatic resuscitation decreases the use of allogeneic blood products, the total amount of bleeding, transfusion related side effects, thromboembolic complications and costs. Its effect on each patient's post-operative hemostatic profile is also measured.

We plan to enroll 140 patients having ACLF with variceal bleeding randomized into two groups:

one will be treated conventionally using clinical judgement and standard coagulation tests such as prothrombin time, platelet count, etc. the other treated using a ROTEM-based algorithm. They will be followed for development of rebleeding, complications of transfusion and any signs of infection after hospitalization

Clinical Trial Description

Patients with acute-on-chronic liver failure (ACLF) have coagulation failure in the setting of systemic inflammatory syndrome (SIRS), sepsis and extra-hepatic organ failures. The utility of thromboelastography/thromboelastometry currently has unvalidated clinical benefit in the assessment and reversal of coagulopathy among cirrhotic patients as compared to standard coagulation testing.Need for periprocedural blood transfusion is still high in patients with decompensated cirrhosis or ACLF who present with major bleeding. Allogeneic blood transfusion may be detrimental in patients with cirrhosis, due to volume overload and acute lung injury. Viscoelastic testing of global coagulation such as thromboelastometry has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. In prior studies, we have clarified the pathophysiology of hemostasis in relation to the evidence of sepsis in liver disease and described the accuracy of various available laboratory tests in assessment of these patients. We have described the role of endogenous heparinoids in severe alcoholic hepatitis and the pathogenesis of the coagulation defect in ACLF. We determined the influence of sepsis on coagulation disorders in ACLF patients, to correctly identify the type and optimal quantity of blood product requirement in at risk patients. ;

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• Cirrhosis, Liver
• End Stage Liver Disease
• Hemorrhage
• Hepatic Insufficiency
• Liver Cirrhosis
• Liver Failure
• Thromboelastometry
• Thrombosis
• Variceal Hemorrhage

• NCT number: NCT05124041
• Study type: Interventional
• Source: Postgraduate Institute of Medical Education and Research
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Completion date: May 15, 2024