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The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

Primary Purpose

Cirrhosis, Coagulopathy

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Blood transfusion
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis, Coagulopathy

Eligibility Criteria

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

Inclusion Criteria:

  • All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy

Exclusion Criteria:

  • Patients on blood thinners (prophylactic anticoagulation is permissible)
  • Hemodynamically unstable patients requiring pressors (ie ICU level patients)
  • Pregnant or lactating individuals
  • Inability to provide consent for any reason

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    TEG

    Prothrombin Time (PT)/International normalized ratio (INR)

    Arm Description

    Blood transfusion

    Blood transfusion

    Outcomes

    Primary Outcome Measures

    Units of fresh frozen plasma (FFP) and platelet transfused
    Will compare how much FFP and platelet transfusion patients receiving between 2 groups.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2016
    Last Updated
    January 19, 2021
    Sponsor
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02990273
    Brief Title
    The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures
    Official Title
    The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Terminated
    Why Stopped
    No funding source available which was required for IRB approval
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    January 19, 2021 (Actual)
    Study Completion Date
    January 19, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University

    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
    Cirrhosis results in decreased synthesis of both procoagulants and anticoagulants resulting in "rebalanced homeostasis". However, conventional blood tests (platelets/ INR levels) that are performed prior to invasive procedures do not accurately reflect the coagulation changes that occur in cirrhotics, resulting in unnecessary transfusion of blood products. Thromboelastography (TEG) is a global hemostasis assessment tool that is being used in surgery (including liver transplant) to help guide blood product transfusion in the operating room. The investigators would like to compare the use of TEG vs. INR/platelets to help guide blood product transfusion in cirrhotic patients undergoing inpatient endoscopy. The investigators will evaluate to see if there is a decrease in prophylactic blood transfusions prior to endoscopy when using TEG.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cirrhosis, Coagulopathy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    TEG
    Arm Type
    Active Comparator
    Arm Description
    Blood transfusion
    Arm Title
    Prothrombin Time (PT)/International normalized ratio (INR)
    Arm Type
    Active Comparator
    Arm Description
    Blood transfusion
    Intervention Type
    Biological
    Intervention Name(s)
    Blood transfusion
    Primary Outcome Measure Information:
    Title
    Units of fresh frozen plasma (FFP) and platelet transfused
    Description
    Will compare how much FFP and platelet transfusion patients receiving between 2 groups.
    Time Frame
    2 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All 18 yo + cirrhotic patients who are being scheduled for inpatient endoscopy Exclusion Criteria: Patients on blood thinners (prophylactic anticoagulation is permissible) Hemodynamically unstable patients requiring pressors (ie ICU level patients) Pregnant or lactating individuals Inability to provide consent for any reason
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tinsay Woreta
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

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