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The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02990273
Recruitment Status : Suspended (IRB lapsed so we are in the process of resubmitting)
First Posted : December 13, 2016
Last Update Posted : December 18, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Cirrhosis, Coagulopathy Biological: Blood transfusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Utility of Thromboelastography in Cirrhotic Patients Undergoing Endoscopic Procedures
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: TEG
Blood transfusion
Biological: Blood transfusion
Active Comparator: PT/INR
Blood transfusion
Biological: Blood transfusion



Primary Outcome Measures :
  1. Units of fresh frozen plasma and platelet trasnfused [ Time Frame: 2 week ]
    Will compare how much PPF and platelet transfusion patients receiving between 2 groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02990273


Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Tinsay Woreta Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02990273    
Other Study ID Numbers: IRB00113092
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders