Empiric Calcium in Massive Transfusion

NCT05953376 | Withdrawn Phase 3

• 1 other identifier: 3115
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemorrhage; Trauma; Hypocalcemia; Shock, Hemorrhagic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mortality

  30-day mortality

• Vasopressor use

  During first 24 hours of resuscitation

Study Arms (2)

Empiric calcium administration

EXPERIMENTAL

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

Drug: Calcium Gluconate

No empiric calcium administration

NO INTERVENTION

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

Interventions

Calcium Gluconate DRUG

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.

Also known as: Calcium

Empiric calcium administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trauma patients receiving massive transfusion protocol

You may not qualify if:

• Pregnancy
• Prisoners
• Known history of hypercalcemia
• Active hyperparathyroidism
• Hemophilia

Sponsors & Collaborators

• University of California, Irvine: lead

Related Publications (4)

• 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.

  PMID: 34269436 BACKGROUND

• 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.

  PMID: 27083965 BACKGROUND

• 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.

  PMID: 35748676 BACKGROUND

• 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.

  PMID: 36675724 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Wounds and Injuries; Hypocalcemia; Shock, Hemorrhagic

Interventions

Calcium Gluconate; Calcium

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Shock

Intervention Hierarchy (Ancestors)

Gluconates; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Jeffry Nahmias, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: July 20, 2023
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03