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Viscoelastic Tests-Guided Therapy In Liver Transplantation (VETLT)

Primary Purpose

Liver Transplant; Complications, Bleeding, Hemostatic Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Usual Care
Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplant; Complications focused on measuring Liver Transplantation, Blood Coagulation Disorders, Blood Transfusion, Hemostasis, Thromboelastometry

Eligibility Criteria

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

Inclusion Criteria:

  • Deceased Donor Liver Transplantation
  • Chronic Liver Disease

Exclusion Criteria:

  • Acute Liver Failure
  • Combined Transplantation
  • Re-Transplantation is Less Than 30 Days After the First Transplant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Usual Care (Before)

    Thromboelastometry-Guided Therapy (After)

    Arm Description

    No Thromboelastometry No Synthetic Factor Concentrates Usual Care

    Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

    Outcomes

    Primary Outcome Measures

    Need of Any Blood Products Transfusion
    Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets.

    Secondary Outcome Measures

    Use of Synthetic Factor Concentrates or Antifibrinolytic
    Any use of synthetic factor concentrates or antifibrinolytic
    Clinical Complications Related to the Procedure
    Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event
    Duration of Mechanical Ventilation
    Duration of mechanical ventilation in the post-operative period
    ICU Length of Stay
    Duration of stay in the intensive care unit
    Hospital Length of Stay
    Duration of stay in the hospital
    In-Hospital Mortality
    Any death during hospitalization

    Full Information

    First Posted
    November 16, 2018
    Last Updated
    November 27, 2018
    Sponsor
    Hospital Israelita Albert Einstein
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03756948
    Brief Title
    Viscoelastic Tests-Guided Therapy In Liver Transplantation
    Acronym
    VETLT
    Official Title
    Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2007 (Actual)
    Primary Completion Date
    October 30, 2015 (Actual)
    Study Completion Date
    January 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital Israelita Albert Einstein

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation. METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Liver Transplant; Complications, Bleeding, Hemostatic Disorder
    Keywords
    Liver Transplantation, Blood Coagulation Disorders, Blood Transfusion, Hemostasis, Thromboelastometry

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    237 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care (Before)
    Arm Type
    Active Comparator
    Arm Description
    No Thromboelastometry No Synthetic Factor Concentrates Usual Care
    Arm Title
    Thromboelastometry-Guided Therapy (After)
    Arm Type
    Experimental
    Arm Description
    Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care
    Intervention Description
    Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
    Intervention Type
    Other
    Intervention Name(s)
    Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
    Intervention Description
    Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
    Primary Outcome Measure Information:
    Title
    Need of Any Blood Products Transfusion
    Description
    Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets.
    Time Frame
    48 Hours
    Secondary Outcome Measure Information:
    Title
    Use of Synthetic Factor Concentrates or Antifibrinolytic
    Description
    Any use of synthetic factor concentrates or antifibrinolytic
    Time Frame
    48 Hours
    Title
    Clinical Complications Related to the Procedure
    Description
    Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event
    Time Frame
    Third days or until hospital discharge, whichever occurs first
    Title
    Duration of Mechanical Ventilation
    Description
    Duration of mechanical ventilation in the post-operative period
    Time Frame
    Third days or until hospital discharge, whichever occurs first
    Title
    ICU Length of Stay
    Description
    Duration of stay in the intensive care unit
    Time Frame
    Third days or until ICU discharge, whichever occurs first
    Title
    Hospital Length of Stay
    Description
    Duration of stay in the hospital
    Time Frame
    Third days or until hospital discharge, whichever occurs first
    Title
    In-Hospital Mortality
    Description
    Any death during hospitalization
    Time Frame
    Third days or until hospital discharge, whichever occurs first

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Deceased Donor Liver Transplantation Chronic Liver Disease Exclusion Criteria: Acute Liver Failure Combined Transplantation Re-Transplantation is Less Than 30 Days After the First Transplant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ary Serpa Neto, MD, MSc, PhD
    Organizational Affiliation
    Physician and Researcher
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Raffael PC Zamper, MD
    Organizational Affiliation
    Raffael
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    23478547
    Citation
    Rana A, Petrowsky H, Hong JC, Agopian VG, Kaldas FM, Farmer D, Yersiz H, Hiatt JR, Busuttil RW. Blood transfusion requirement during liver transplantation is an important risk factor for mortality. J Am Coll Surg. 2013 May;216(5):902-7. doi: 10.1016/j.jamcollsurg.2012.12.047. Epub 2013 Mar 9.
    Results Reference
    background
    PubMed Identifier
    26819521
    Citation
    Hartmann M, Szalai C, Saner FH. Hemostasis in liver transplantation: Pathophysiology, monitoring, and treatment. World J Gastroenterol. 2016 Jan 28;22(4):1541-50. doi: 10.3748/wjg.v22.i4.1541.
    Results Reference
    background
    PubMed Identifier
    15784122
    Citation
    Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
    Results Reference
    background
    PubMed Identifier
    22914710
    Citation
    Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644.
    Results Reference
    background
    PubMed Identifier
    20832550
    Citation
    Wang SC, Shieh JF, Chang KY, Chu YC, Liu CS, Loong CC, Chan KH, Mandell S, Tsou MY. Thromboelastography-guided transfusion decreases intraoperative blood transfusion during orthotopic liver transplantation: randomized clinical trial. Transplant Proc. 2010 Sep;42(7):2590-3. doi: 10.1016/j.transproceed.2010.05.144.
    Results Reference
    background
    PubMed Identifier
    30579327
    Citation
    Zamper RPC, Amorim TC, Queiroz VNF, Lira JDO, Costa LGV, Takaoka F, Juffermans NP, Neto AS. Association between viscoelastic tests-guided therapy with synthetic factor concentrates and allogenic blood transfusion in liver transplantation: a before-after study. BMC Anesthesiol. 2018 Dec 22;18(1):198. doi: 10.1186/s12871-018-0664-8.
    Results Reference
    derived

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    Viscoelastic Tests-Guided Therapy In Liver Transplantation

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