Thromboelastographic Guide for Blood Products in Cirrhotics
Primary Purpose
Liver Cirrhosis, Coagulation Disorder
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Thromboelastography to guide blood products infusion
Standard of care coagulation tests to guide blood products infusion
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Histologic or imaging-proven liver cirrhosis of any etiology
- INR>1.8 and/or PLTs count <50x103/μl
Exclusion Criteria:
- Ongoing bleeding
- Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel
- Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study
- Presence of sepsis according to ACP-SCCP criteria
- Hemodialysis performed within 7 days
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Thromboelastography (TEG)
Standard of Care (SOC)
Arm Description
Patients in the TEG group received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, only if INR was higher than 1.8 and r time longer than 40 minutes. They received platelets at the amount of 1 apheresis Unit, only if platelets count was lower than 50000/μl and MA was shorter than 30 millimeter.
In the SOC group patients received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, when INR was higher than 1.8. They received platelets at the amount of 1 apheresis Unit, when platelets count was lower than 50000/μl.
Outcomes
Primary Outcome Measures
Comparison in the amount of blood products transfused between the groups
Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups
Secondary Outcome Measures
Post-procedure bleeding
Comparison of the number of patients having bleeding episodes after procedure between the study groups
Survival
Comparison of patients survival between the study groups
Transfusion related side effects
Comparison of the number of patients presenting transfusion side effects between the study groups
Procedure-related complications
Comparison of the number of patients presenting post-procedures complication other than bleeding between the study groups
Comparison between blood products costs between groups
Full Information
NCT ID
NCT02362178
First Posted
January 23, 2015
Last Updated
February 11, 2015
Sponsor
University of Modena and Reggio Emilia
1. Study Identification
Unique Protocol Identification Number
NCT02362178
Brief Title
Thromboelastographic Guide for Blood Products in Cirrhotics
Official Title
USE OF THROMBOELASTOGRAPHY TO GUIDE BLOOD PRODUCTS REPLACEMENT IN DECOMPENSATED CIRRHOTIC PATIENTS UNDERGOING INVASIVE PROCEDURES
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Modena and Reggio Emilia
4. Oversight
5. Study Description
Brief Summary
Blood products are commonly used before invasive procedures in patients with end-stage liver diseases despite cirrhosis being a thrombophylic state. Traditional coagulation tests (namely INR and PLTs count) are known to be unreliable in predicting bleeding risk before invasive procedures and in representing the real coagulation status of cirrhotic patients. Notwithstanding they are still used to guide blood products administration before invasive procedures. Thromboelastography (TEG) has been shown to be effective in detecting signs of hypo-hypercoagulability possibly being an alternative method to guide blood products transfusion. The aim of this randomized controlled study was to evaluate the efficacy of TEG as a guide for blood products transfusion in cirrhotic patients undergoing invasive procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Coagulation Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thromboelastography (TEG)
Arm Type
Experimental
Arm Description
Patients in the TEG group received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, only if INR was higher than 1.8 and r time longer than 40 minutes. They received platelets at the amount of 1 apheresis Unit, only if platelets count was lower than 50000/μl and MA was shorter than 30 millimeter.
Arm Title
Standard of Care (SOC)
Arm Type
Active Comparator
Arm Description
In the SOC group patients received fresh frozen plasma at the dose of 10 ml/kg of ideal body weight, when INR was higher than 1.8. They received platelets at the amount of 1 apheresis Unit, when platelets count was lower than 50000/μl.
Intervention Type
Procedure
Intervention Name(s)
Thromboelastography to guide blood products infusion
Intervention Description
A TEG has been performed before invasive procedure and blood products infusion has been decided according to TEG parameters as follow: fresh frozen plasma (FFP 10 ml/kg) in case of r time>40 mm and/or platelets (PLTs 10 units/Kg) for MA<30 mm
Intervention Type
Procedure
Intervention Name(s)
Standard of care coagulation tests to guide blood products infusion
Intervention Description
Patients received FFP (10 ml/kg) if INR>1.8 and/or PLTS (10 units/Kg) If PLTs count < 50000/μl
Primary Outcome Measure Information:
Title
Comparison in the amount of blood products transfused between the groups
Description
Comparison of the number of patients receiving blood products (FFPor PLTs or both), and the amount of blood products between the study groups
Time Frame
48 hours from admission
Secondary Outcome Measure Information:
Title
Post-procedure bleeding
Description
Comparison of the number of patients having bleeding episodes after procedure between the study groups
Time Frame
48 hours from admission
Title
Survival
Description
Comparison of patients survival between the study groups
Time Frame
90 days patient survival
Title
Transfusion related side effects
Description
Comparison of the number of patients presenting transfusion side effects between the study groups
Time Frame
48 hours from admission
Title
Procedure-related complications
Description
Comparison of the number of patients presenting post-procedures complication other than bleeding between the study groups
Time Frame
during hospitalization (mean 4 weeks)
Title
Comparison between blood products costs between groups
Time Frame
48 hours from admission
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologic or imaging-proven liver cirrhosis of any etiology
INR>1.8 and/or PLTs count <50x103/μl
Exclusion Criteria:
Ongoing bleeding
Previous or current thrombotic events defined as any documented blood clot in a venous or arterial vessel
Ongoing antiplatelet or anticoagulant therapy or stopped less than 7 days before evaluation for the study
Presence of sepsis according to ACP-SCCP criteria
Hemodialysis performed within 7 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lesley De pietri, MD
Organizational Affiliation
Azienda Ospedaliero-Universitaria di Modena-Policlinico, Division of Anaesthesiology and Intensive Care Unit
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Thromboelastographic Guide for Blood Products in Cirrhotics
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