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Empiric Calcium in Massive Transfusion

Primary Purpose

Hemorrhage, Trauma, Hypocalcemia

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Calcium Gluconate
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage

Eligibility Criteria

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

Inclusion Criteria: Trauma patients receiving massive transfusion protocol Exclusion Criteria: Pregnancy Prisoners Known history of hypercalcemia Active hyperparathyroidism Hemophilia

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Empiric calcium administration

    No empiric calcium administration

    Arm Description

    Patients in this arm will receive 2g IV calcium with the initial transfusion

    Patients in this arm will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion

    Outcomes

    Primary Outcome Measures

    Transfusion requirements
    Number of packed red blood cells, whole blood, fresh frozen plasma, platelets and cryo units given

    Secondary Outcome Measures

    Mortality
    30-day mortality or until discharge (whichever is longer)
    Vasopressor use
    Amount of vasopressor used within the first 24 hours measured in levophed equivalents

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    July 11, 2023
    Sponsor
    University of California, Irvine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05953376
    Brief Title
    Empiric Calcium in Massive Transfusion
    Official Title
    Empiric Calcium Versus Lab Based Treatment in Massive Transfusion Trauma Patients: A Feasibility Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Irvine

    4. Oversight

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

    5. Study Description

    Brief Summary
    Calcium helps blood to clot and thereby stop bleeding. Trauma patients who experience large volume blood loss often require blood transfusions and bleeding is the most common cause of death. The purpose of this study is to see if giving intravenous calcium immediately to patients who require large volume blood transfusion will decrease transfusion requirements, vasopressor use and mortality in bleeding trauma patients.
    Detailed Description
    Advancements in the area of transfusion and blood product administration have occurred with the use of viscoelastic assays and whole blood. However, as we resuscitate trauma patients with blood products, hypocalcemia is an inadvertent side-effect. Citrate within stored blood binds calcium, causing patients to have hypocalcemia. In addition, outside of transfusion related hypocalcemia there is an independent trauma/inflammation related mechanism for hypocalcemia in the trauma patient. Furthermore, Calcium is a critical component of the coagulation cascade, and therefore a highly important component of hemostatic resuscitation. Hall et al found that patients receiving 13 or more units of PRBCs had a much higher prevalence of severe hypocalcemia and at least one ionized calcium <1.0mmol/L. Kronstedt el al reported an association between hypocalcemia and mortality in trauma patients receiving massive transfusion. Despite evidence that hypocalcemia occurs with transfusion, and evidence that hypocalcemia in patients with hemorrhagic shock may be associated with increased mortality, there are no randomized controlled trials evaluating the administration of calcium in trauma resuscitation. Currently, the Joint Trauma System revised guidelines for damage control resuscitation from 2019 recommend administering 1g of calcium after the first unit of blood transfusion, and an additional 1g after no more than 4 units of blood administration. However, these recommendations are based on small cohort studies or retrospective studies. The purpose of this study is to evaluate the efficacy of early empiric intravenous calcium administration on transfusion requirements, vasopressor use and mortality in hemorrhaging trauma patients with initiation of a massive transfusion. All trauma patients in which massive transfusion is initiated within 6 hours of arrival will be enrolled. Two study arms will be created, one will receive 2g IV calcium with the initial transfusion and the other will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion. All critical trauma activations will get a baseline ionized calcium as part of their initial labs.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemorrhage, Trauma, Hypocalcemia, Shock, Hemorrhagic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Empiric calcium administration
    Arm Type
    Experimental
    Arm Description
    Patients in this arm will receive 2g IV calcium with the initial transfusion
    Arm Title
    No empiric calcium administration
    Arm Type
    No Intervention
    Arm Description
    Patients in this arm will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion
    Intervention Type
    Drug
    Intervention Name(s)
    Calcium Gluconate
    Other Intervention Name(s)
    Calcium
    Intervention Description
    There will be 2 study arms, one will receive 2g IV calcium with the initial transfusion and the other will only receive calcium supplementation based on routine ionized calcium levels and/or physician discretion.
    Primary Outcome Measure Information:
    Title
    Transfusion requirements
    Description
    Number of packed red blood cells, whole blood, fresh frozen plasma, platelets and cryo units given
    Time Frame
    During first 24 hours of resuscitation
    Secondary Outcome Measure Information:
    Title
    Mortality
    Description
    30-day mortality or until discharge (whichever is longer)
    Time Frame
    30-day mortality
    Title
    Vasopressor use
    Description
    Amount of vasopressor used within the first 24 hours measured in levophed equivalents
    Time Frame
    During first 24 hours of resuscitation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Trauma patients receiving massive transfusion protocol Exclusion Criteria: Pregnancy Prisoners Known history of hypercalcemia Active hyperparathyroidism Hemophilia
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jeffry Nahmias, MD
    Phone
    714-456-5890
    Email
    jnahmias@hs.uci.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mallory Jebbia, MD
    Phone
    714-456-5860
    Email
    mjebbia@hs.uci.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jeffry Nahmias, MD
    Organizational Affiliation
    University of California, Irvine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34269436
    Citation
    Hall C, Nagengast AK, Knapp C, Behrens B, Dewey EN, Goodman A, Bommiasamy A, Schreiber M. Massive transfusions and severe hypocalcemia: An opportunity for monitoring and supplementation guidelines. Transfusion. 2021 Jul;61 Suppl 1:S188-S194. doi: 10.1111/trf.16496.
    Results Reference
    background
    PubMed Identifier
    27083965
    Citation
    Giancarelli A, Birrer KL, Alban RF, Hobbs BP, Liu-DeRyke X. Hypocalcemia in trauma patients receiving massive transfusion. J Surg Res. 2016 May 1;202(1):182-7. doi: 10.1016/j.jss.2015.12.036. Epub 2015 Dec 30.
    Results Reference
    background
    PubMed Identifier
    35748676
    Citation
    Kronstedt S, Roberts N, Ditzel R, Elder J, Steen A, Thompson K, Anderson J, Siegler J. Hypocalcemia as a predictor of mortality and transfusion. A scoping review of hypocalcemia in trauma and hemostatic resuscitation. Transfusion. 2022 Aug;62 Suppl 1(Suppl 1):S158-S166. doi: 10.1111/trf.16965. Epub 2022 Jun 24.
    Results Reference
    background
    PubMed Identifier
    36675724
    Citation
    Vettorello M, Altomare M, Spota A, Cioffi SPB, Rossmann M, Mingoli A, Chiara O, Cimbanassi S. Early Hypocalcemia in Severe Trauma: An Independent Risk Factor for Coagulopathy and Massive Transfusion. J Pers Med. 2022 Dec 28;13(1):63. doi: 10.3390/jpm13010063.
    Results Reference
    background

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    Empiric Calcium in Massive Transfusion

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