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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
University of Modena and Reggio Emilia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 23, 2015
    Last Updated
    February 11, 2015
    Sponsor
    University of Modena and Reggio Emilia
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    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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