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Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis (STRATEGIC)

Primary Purpose

Cirrhosis, Liver, Coagulopathy, GastroIntestinal Bleeding

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thromboelastography
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cirrhosis, Liver

Eligibility Criteria

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

Inclusion Criteria:

  • Patient aged 18 years or older
  • Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis

Exclusion Criteria:

  • None

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Usual Care

    Thromboelastography guided resuscitation

    Arm Description

    Patients will receive usual care at the discretion of their providers.

    Patients will undergo thromboelastography testing that will be used by primary providers to guide blood product resuscitation.

    Outcomes

    Primary Outcome Measures

    Volume of fresh frozen plasma transfused
    The total volume of fresh frozen plasma transfused

    Secondary Outcome Measures

    Patients requiring fresh frozen plasma transfusion
    Percentage of patients requiring a fresh frozen plasma transfusion
    Volume of platelets and cryoprecipitate transfused
    The total combined volume of platelets and cryoprecipitate transfused
    Control of bleeding at 5 days
    Percentage of patients who have bleeding controlled at 5 days
    Rebleeding at 42 days
    Percentage of patients who experienced in-hospital rebleeding within 42 days
    Mortality rate during index hospitalization
    Percentage of patients who died during the index hospitalization

    Full Information

    First Posted
    October 8, 2022
    Last Updated
    April 3, 2023
    Sponsor
    Vanderbilt University Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05583539
    Brief Title
    Thromboelastography Guided Blood Product Transfusion for Upper Gastrointestinal Bleeding in Cirrhosis
    Acronym
    STRATEGIC
    Official Title
    A Pilot Study of Thromboelastography Guided Blood Product Transfusion for Patient With Cirrhosis and Upper Gastrointestinal Bleeding
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 16, 2025 (Anticipated)
    Primary Completion Date
    June 15, 2025 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vanderbilt University Medical Center

    4. Oversight

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

    5. Study Description

    Brief Summary
    The goal of this clinical trial is to compare resuscitation strategies in patients with cirrhosis and gastrointestinal bleeding. The main question it aims to answer is whether thromboelastography guided resuscitation decreased the amount of fresh frozen plasma patients receive. Patients will receive blood products guided by thromboelastography in the intervention group. Researchers will compare the patients who undergo thromboelastography guided resuscitation to those who receive usual care to see which strategy leads to the use of less blood products, specifically less fresh frozen plasma.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    Patients will receive usual care at the discretion of their providers.
    Arm Title
    Thromboelastography guided resuscitation
    Arm Type
    Experimental
    Arm Description
    Patients will undergo thromboelastography testing that will be used by primary providers to guide blood product resuscitation.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Thromboelastography
    Intervention Description
    Thromboelastography is a viscoelastic test that measures the dynamics of blood clotting on whole blood samples.
    Primary Outcome Measure Information:
    Title
    Volume of fresh frozen plasma transfused
    Description
    The total volume of fresh frozen plasma transfused
    Time Frame
    From time of randomization to hospital discharge, up to 3 months
    Secondary Outcome Measure Information:
    Title
    Patients requiring fresh frozen plasma transfusion
    Description
    Percentage of patients requiring a fresh frozen plasma transfusion
    Time Frame
    From time of randomization to hospital discharge, up to 3 months
    Title
    Volume of platelets and cryoprecipitate transfused
    Description
    The total combined volume of platelets and cryoprecipitate transfused
    Time Frame
    From time of randomization to hospital discharge, up to 3 months
    Title
    Control of bleeding at 5 days
    Description
    Percentage of patients who have bleeding controlled at 5 days
    Time Frame
    Measured at 5 days from the time of octreotide order placement
    Title
    Rebleeding at 42 days
    Description
    Percentage of patients who experienced in-hospital rebleeding within 42 days
    Time Frame
    The earlier of 42 days from the time of octreotide placement or hospital discharge
    Title
    Mortality rate during index hospitalization
    Description
    Percentage of patients who died during the index hospitalization
    Time Frame
    From time of randomization to hospital discharge, up to 3 months
    Other Pre-specified Outcome Measures:
    Title
    Rate of transfusion reactions
    Description
    Percentage of patients who experienced a transfusion reaction
    Time Frame
    From time of randomization to hospital discharge, up to 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient aged 18 years or older Octreotide order placed for the indication of upper gastrointestinal bleeding in cirrhosis Exclusion Criteria: None
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tanya Marvi, MD
    Phone
    615-322-3412
    Email
    tanya.marvi@vumc.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tanya Marvi, MD
    Organizational Affiliation
    Vanderbilt University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    3308669
    Citation
    Lautt WW, Greenway CV. Conceptual review of the hepatic vascular bed. Hepatology. 1987 Sep-Oct;7(5):952-63. doi: 10.1002/hep.1840070527. No abstract available.
    Results Reference
    background
    PubMed Identifier
    12939586
    Citation
    D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385.
    Results Reference
    background
    PubMed Identifier
    21751907
    Citation
    Tripodi A, Mannucci PM. The coagulopathy of chronic liver disease. N Engl J Med. 2011 Jul 14;365(2):147-56. doi: 10.1056/NEJMra1011170. No abstract available.
    Results Reference
    background
    PubMed Identifier
    17593061
    Citation
    Tripodi A, Caldwell SH, Hoffman M, Trotter JF, Sanyal AJ. Review article: the prothrombin time test as a measure of bleeding risk and prognosis in liver disease. Aliment Pharmacol Ther. 2007 Jul 15;26(2):141-8. doi: 10.1111/j.1365-2036.2007.03369.x.
    Results Reference
    background
    PubMed Identifier
    32058387
    Citation
    Nanchal R, Subramanian R, Karvellas CJ, Hollenberg SM, Peppard WJ, Singbartl K, Truwit J, Al-Khafaji AH, Killian AJ, Alquraini M, Alshammari K, Alshamsi F, Belley-Cote E, Cartin-Ceba R, Dionne JC, Galusca DM, Huang DT, Hyzy RC, Junek M, Kandiah P, Kumar G, Morgan RL, Morris PE, Olson JC, Sieracki R, Steadman R, Taylor B, Alhazzani W. Guidelines for the Management of Adult Acute and Acute-on-Chronic Liver Failure in the ICU: Cardiovascular, Endocrine, Hematologic, Pulmonary, and Renal Considerations. Crit Care Med. 2020 Mar;48(3):e173-e191. doi: 10.1097/CCM.0000000000004192.
    Results Reference
    background
    PubMed Identifier
    30986390
    Citation
    O'Leary JG, Greenberg CS, Patton HM, Caldwell SH. AGA Clinical Practice Update: Coagulation in Cirrhosis. Gastroenterology. 2019 Jul;157(1):34-43.e1. doi: 10.1053/j.gastro.2019.03.070. Epub 2019 Apr 12.
    Results Reference
    background
    PubMed Identifier
    31008867
    Citation
    Rout G, Shalimar, Gunjan D, Mahapatra SJ, Kedia S, Garg PK, Nayak B. Thromboelastography-guided Blood Product Transfusion in Cirrhosis Patients With Variceal Bleeding: A Randomized Controlled Trial. J Clin Gastroenterol. 2020 Mar;54(3):255-262. doi: 10.1097/MCG.0000000000001214.
    Results Reference
    background
    PubMed Identifier
    31148204
    Citation
    Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial. Hepatology. 2020 Jan;71(1):235-246. doi: 10.1002/hep.30794. Epub 2019 Aug 27.
    Results Reference
    background

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