Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy

Cirrhosis, Liver Clinical Trial

— GOODHEART-ACLF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05124041
• Other study ID #: PGI/IEC/2020/000268
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: May 15, 2024

Study information

• Verified date: April 2023
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: May 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18-65 years
• ACLF, as diagnosed by CANONIC/ APASL criteria .
• Upper gastrointestinal bleeding

Exclusion Criteria:

• Current therapy: Recent blood or blood component transfusion in the last 2 weeks.
• HIV positive/ AIDS patients
• Patients requiring antiplatelet therapy,
• Renal insufficiency requiring dialysis
• Active malignancy within the last 5 years
• Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease
• Administration of anticoagulants, antifibrinolytics,
• Not willing to participate in the study

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

Intervention

Diagnostic Test:
• Rotational thromboelastometry
ROTEM-guided protocol of hemostatic resuscitation

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh	Choose Any State/Province

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with clinical control of bleeding	Clinical control of bleeding at 24 hours, at Day 5 and day 42	24 hours
Primary	Number of participants with clinical control of bleeding	Clinical control of bleeding at 24 hours, at Day 5 and day 42	5 days
Primary	Number of participants with clinical control of bleeding	Clinical control of bleeding at 24 hours, at Day 5 and day 42	42 days
Secondary	Duration of Intensive care admission		30 days after bleeding episode treated by transfusion protocol
Secondary	Duration of hospital stay		30 days after bleeding episode treated by transfusion protocol
Secondary	Number of Participants with Transfusion-related side effects		30 days after bleeding episode treated by transfusion protocol
Secondary	Number of Participants with Thromboembolic events		30 days after bleeding episode treated by transfusion protocol