Empiric Calcium in Massive Transfusion

Trauma Clinical Trial

Official title:

Empiric Calcium Versus Lab Based Treatment in Massive Transfusion Trauma Patients: A Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05953376
• Other study ID #: 3115
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2025
• Est. completion date: December 2026

Study information

• Verified date: April 2024
• Source: University of California, Irvine
• Contact: Jeffry Nahmias, MD
• Phone: 714-456-5890
• Email: jnahmias[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Trauma patients receiving massive transfusion protocol

Exclusion Criteria:

• Pregnancy

• Prisoners

• Known history of hypercalcemia

• Active hyperparathyroidism

• Hemophilia

Related Conditions & MeSH terms

• Hemorrhage
• Hypocalcemia
• Shock, Hemorrhagic
• Trauma

Intervention

Drug:
• Calcium Gluconate
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion requirements	Number of packed red blood cells, whole blood, fresh frozen plasma, platelets and cryo units given	During first 24 hours of resuscitation
Secondary	Mortality	30-day mortality or until discharge (whichever is longer)	30-day mortality
Secondary	Vasopressor use	Amount of vasopressor used within the first 24 hours measured in levophed equivalents	During first 24 hours of resuscitation