Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy (GOODHEART-ACLF)
Primary Purpose
Acute on Chronic Liver Failure, Variceal Hemorrhage, Cirrhosis, Liver
Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Rotational thromboelastometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute on Chronic Liver Failure
Eligibility Criteria
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
Sites / Locations
- Postgraduate Institute of Medical Education and ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ROTEM-arm
Control-arm
Arm Description
Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis
Treatment of significant blood loss conventionally, ie. using clinical judgement and conventional coagulation tests, such as prothrombin time (as international normalized ratio, INR), activated partial thrombin time (APTT), fibrinogen in plasma
Outcomes
Primary Outcome Measures
Number of participants with clinical control of bleeding
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Number of participants with clinical control of bleeding
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Number of participants with clinical control of bleeding
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Secondary Outcome Measures
Duration of Intensive care admission
Duration of hospital stay
Number of Participants with Transfusion-related side effects
Number of Participants with Thromboembolic events
Full Information
NCT ID
NCT05124041
First Posted
November 5, 2021
Last Updated
April 28, 2023
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT05124041
Brief Title
Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy
Acronym
GOODHEART-ACLF
Official Title
Thromboelastometry Guided Transfusion Protocol Versus Standard Care in Acute-on-Chronic Liver Failure With Bleeding: A Prospective Intervention Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Liver Failure, Variceal Hemorrhage, Cirrhosis, Liver, Thromboelastometry, Thrombosis;Portal
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
140 patients having ACLF with bleeding will be randomized into two groups. One will be treated conventionally, i.e. using clinical judgement and conventional coagulation tests, the other treated using a ROTEM-based algorithm
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ROTEM-arm
Arm Type
Experimental
Arm Description
Treatment of significant blood loss using point-of-care testing of whole blood viscoelasticity (ROTEM) monitoring coagulopathy or hyperfibrinolysis
Arm Title
Control-arm
Arm Type
Active Comparator
Arm Description
Treatment of significant blood loss conventionally, ie. using clinical judgement and conventional coagulation tests, such as prothrombin time (as international normalized ratio, INR), activated partial thrombin time (APTT), fibrinogen in plasma
Intervention Type
Diagnostic Test
Intervention Name(s)
Rotational thromboelastometry
Intervention Description
ROTEM-guided protocol of hemostatic resuscitation
Primary Outcome Measure Information:
Title
Number of participants with clinical control of bleeding
Description
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Time Frame
24 hours
Title
Number of participants with clinical control of bleeding
Description
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Time Frame
5 days
Title
Number of participants with clinical control of bleeding
Description
Clinical control of bleeding at 24 hours, at Day 5 and day 42
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Duration of Intensive care admission
Time Frame
30 days after bleeding episode treated by transfusion protocol
Title
Duration of hospital stay
Time Frame
30 days after bleeding episode treated by transfusion protocol
Title
Number of Participants with Transfusion-related side effects
Time Frame
30 days after bleeding episode treated by transfusion protocol
Title
Number of Participants with Thromboembolic events
Time Frame
30 days after bleeding episode treated by transfusion protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
State/Province
Choose Any State/Province
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madhumita Premkumar, MD DM
Phone
0172-2754777
Email
drmadhumitap@gmail.com
First Name & Middle Initial & Last Name & Degree
Harmanpreet Kaur, MSc
Phone
0172-2754777
Email
harmandhaliwal635@yahoo.com
First Name & Middle Initial & Last Name & Degree
Harmanpreet Kaur Kaur, MSc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Goal-Directed Hemostatic Resuscitation Trial in ACLF Induced Coagulopathy
We'll reach out to this number within 24 hrs