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To Compare Relaxed Rotational Thromboelastometry Cut-offs With Standard Cut-offs for Guiding Blood Product Use Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure Patients

Primary Purpose

Liver Cirrhosis, Acute on Chronic Liver Failure

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Relaxed Rotational Thromboelastometry
Standard Coagulation Tests
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: - All Cirrhosis and/or ACLF patients >18 yrs, scheduled to undergo an high risk invasive procedure with severe coagulopathy requiring correction as per risk category and degree of coagulopathy on conventional coagulation tests. Exclusion Criteria: Ongoing bleeding Bleeding within last 3 days ACLF patients going for LT may be added in exclusion criteria Antiplatelet or anticoagulant therapy (discontinued <7 d before) Hemodialysis in last 3 days

Sites / Locations

  • Institute of Liver & Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Relaxed rotational thromboelastometry

Standard coagulation tests

Arm Description

Relaxed rotational thromboelastometry will be done 12 hr,24 hr,48 hr, 72 hr and if patients bleed.

Standard coagulation tests will be done baseline,12 hr,24 hr,48 hr, 72 hr and if patients bleed

Outcomes

Primary Outcome Measures

To compare the proportion of patients requiring any blood products transfusion (i.e FFP / platelets / cryoprecipitate)

Secondary Outcome Measures

To compare the proportion of patients requiring FFP transfusion
To compare the proportion of patients requiring platelets transfusion
To compare the proportion of patients requiring cryoprecipitate transfusion
To compare the proportion of patients requiring tranexamic acid infusion
To compare the amount of FFP transfused (mL) in patients requiring FFP transfusion per patient
To compare the amount of platelets transfused (SDAP units) in patients requiring platelet transfusion per patient
To compare the amount of cryoprecipitate transfused (units) in patients requiring cryoprecipitate transfusion per patient
To compare the occurrence of bleeding, defined as overt bleeding or hemoglobin drop requiring transfusion with a target of 8 g/dL 28 days patient survival
To compare the transfusion-related side effects, defined as any side effect occurring within 6 hours of blood products infusion; and Procedure-related complications other than bleeding
To compare the cost incurred

Full Information

First Posted
January 3, 2023
Last Updated
June 15, 2023
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT05672589
Brief Title
To Compare Relaxed Rotational Thromboelastometry Cut-offs With Standard Cut-offs for Guiding Blood Product Use Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure Patients
Official Title
To Compare Relaxed Rotational Thromboelastometry Cut-offs With Standard Cut-offs for Guiding Blood Product Use Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure Patients: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypothesis Relaxed ROTEM cutoff guided blood product transfusion will result in less blood products use without increasing bleeding complications for invasive procedures in cirrhosis or acute on chronic liver failure (ACLF) patients AIM:- To evaluate the efficacy and safety of Relaxed threshold (as compared to conventional thresholds) for blood product transfusion for invasive procedures in cirrhosis or acute on chronic liver failure (ACLF) patients Objective - Primary objective: To compare the reduction in amount of total component transfused (ml/kg) in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients. Secondary objectives: To compare the amount of FFP (ml/kg) transfused in Relaxed Rotational Thromboelastometry cut off based versus Standard Rotational Thromboelastometry cut off based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients. To compare the amount of Platelet (ml/kg) transfused in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients. To compare the amount of cryoprecipitate (ml/kg) transfused in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients. To compare the bleeding rate in Relaxed Rotational Thromboelastometry cut off based versus Conventional Rotational Thromboelastometry cut off based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients. To compare the rate of transfusion reactions in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients. To compare the cost incurred in Relaxed Rotational Thromboelastometry based versus Conventional Rotational Thromboelastometry based transfusion strategy in cirrhosis or acute on chronic liver failure (ACLF) patients.
Detailed Description
Methodology Investigator will be following guidelines given by Society of Interventional Radiology for any intervention for coagulopathy correction. Different procedures which are routinely carry out at our institute will be divided into high risk vs low risk as per Society of Interventional Radiology Low risk: Peripherally inserted central catheter placement, Paracentesis, Thoracocentesis, Central venous cannulation, Lumbar puncture, Dialysis catheter placement Low risk: Solid organ biopsies, Transjugular intrahepatic portosystemic shunts, Biliary interventions (cholecystostomy tube placement) If the patient has evidence of ongoing sepsis (Positive blood culture, increased procalcitonin, shock, fever etc) or renal dysfunction, then he will be considered to be at high risk for the procedure. After determining the risk category of the procedure, patients will decide to receive coagulopathy correction based on CCT (Society of Interventional Radiology). Those patients who do not require correction will be excluded. For high risk procedures: PLT < 20, INR >2.5, Fibrinogen < 100 mg/dL For low risk procedures: PLT < 30, INR > 2.0, Fibrinogen < 100 mg/dL Those patients who will require coagulopathy correction will be randomized to receive correction based on standard ROTEM criteria versus Relaxed ROTEM criteria. Standard ROTEM criteria: CT EX >80 s �' FFP/PCC(if volume overload) MCF EX <35 mm MCF FIB <8 mm �' Cryoprecipitate transfusion MCF FIB ≥8 mm �' Platelets transfusion Relaxed ROTEM criteria: CT EX >90 s �' FFP/PCC(if volume overload) MCF EX <30 mm MCF FIB <7 mm �' Cryoprecipitate transfusion MCF FIB ≥7 mm �' Platelets transfusion CCTs and/or ROTEM will be revised 12 hourly for 24 hours, then every 24 hours for next 48 hours; and if bleeding complications occur. However patients will undergo a procedure immediately after the coagulopathy correction based on baseline CCT and/or ROTEM. Patients will be followed up till day 28 post procedure for procedure related bleeding and non bleeding complications. Acute kidney injury: The Kidney Disease Improving Global Outcomes (KDIGO) guidelines define AKI as any of the following: Increase in sCr by ≥0.3 mg/dl within 48 h or Increase in sCr to ≥1.5x baseline, which is known or presumed to have occurred within the prior 7 days or Urine volume <0.5 ml/kg/h for 6 h Sepsis: The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. ● Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection Study population: All Cirrhosis and/or ACLF patients >18 yrs, scheduled to undergo an high risk invasive procedure with severe coagulopathy requiring correction as per risk category and degree of coagulopathy on conventional coagulation tests. Study design: Randomized controlled trial Study period: 1 years Sample size: 1050 Assuming that the proportion of patients requiring any blood products transfusion (i.e either FFP/platelets/ cryoprecipitate), in standard criteria group: 20% [Ref:Pietri etal. HEPATOLOGY 2016;63:566-573] and Relaxed group criteria: 13% (1/3rd decrease). Two-sided significance level(1-alpha): 95 Power(1-beta, % chance of detecting): 80 Ratio of sample size, Unexposed/Exposed: 1 Percent of Unexposed with Outcome: 20 Percent of Exposed with Outcome: 13 Investigator decided to enroll total 1050 patients considering 10% dropout rate, 525 subjects in each arm Patients were randomized to either Relaxed ROTEM or conventional ROTEM transfusion groups in a 1:1 ratio by random computer generated sequence Monitoring and assessment: All the parameters of the objective and also noted any adverse effects. Stopping rule: If patient decided to withdraw from study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Acute on Chronic Liver Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relaxed rotational thromboelastometry
Arm Type
Experimental
Arm Description
Relaxed rotational thromboelastometry will be done 12 hr,24 hr,48 hr, 72 hr and if patients bleed.
Arm Title
Standard coagulation tests
Arm Type
Active Comparator
Arm Description
Standard coagulation tests will be done baseline,12 hr,24 hr,48 hr, 72 hr and if patients bleed
Intervention Type
Diagnostic Test
Intervention Name(s)
Relaxed Rotational Thromboelastometry
Intervention Description
Relaxed rotational thromboelastometry will be done 12 hr,24 hr,48 hr, 72 hr and if patients. bleed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard Coagulation Tests
Intervention Description
Standard coagulation tests will be done baseline,12 hr,24 hr,48 hr, 72 hr and if patients bleed.
Primary Outcome Measure Information:
Title
To compare the proportion of patients requiring any blood products transfusion (i.e FFP / platelets / cryoprecipitate)
Time Frame
0 hours
Secondary Outcome Measure Information:
Title
To compare the proportion of patients requiring FFP transfusion
Time Frame
0 hours
Title
To compare the proportion of patients requiring platelets transfusion
Time Frame
0 hours
Title
To compare the proportion of patients requiring cryoprecipitate transfusion
Time Frame
0 hours
Title
To compare the proportion of patients requiring tranexamic acid infusion
Time Frame
0 hours
Title
To compare the amount of FFP transfused (mL) in patients requiring FFP transfusion per patient
Time Frame
0 hours
Title
To compare the amount of platelets transfused (SDAP units) in patients requiring platelet transfusion per patient
Time Frame
0 hours
Title
To compare the amount of cryoprecipitate transfused (units) in patients requiring cryoprecipitate transfusion per patient
Time Frame
0 hours
Title
To compare the occurrence of bleeding, defined as overt bleeding or hemoglobin drop requiring transfusion with a target of 8 g/dL 28 days patient survival
Time Frame
28 days
Title
To compare the transfusion-related side effects, defined as any side effect occurring within 6 hours of blood products infusion; and Procedure-related complications other than bleeding
Time Frame
6 hours
Title
To compare the cost incurred
Time Frame
0 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - All Cirrhosis and/or ACLF patients >18 yrs, scheduled to undergo an high risk invasive procedure with severe coagulopathy requiring correction as per risk category and degree of coagulopathy on conventional coagulation tests. Exclusion Criteria: Ongoing bleeding Bleeding within last 3 days ACLF patients going for LT may be added in exclusion criteria Antiplatelet or anticoagulant therapy (discontinued <7 d before) Hemodialysis in last 3 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Tushar Madke, MD
Phone
01146300000
Email
drtusharmadke@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
11070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Tushar Madke, MD
Phone
01146300000
Email
drtusharmadke@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

To Compare Relaxed Rotational Thromboelastometry Cut-offs With Standard Cut-offs for Guiding Blood Product Use Before Invasive Procedures in Cirrhosis and Acute on Chronic Liver Failure Patients

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