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
About this trial
This is an interventional treatment trial for Hemorrhage
Eligibility Criteria
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
NCT ID
NCT05953376
First Posted
July 11, 2023
Last Updated
July 11, 2023
Sponsor
University of California, Irvine
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
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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
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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
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Empiric Calcium in Massive Transfusion
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