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Clinical Assessment of Low Calcium In traUMa (CALCIUM)

NCT05885256 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 391

Last updated 2025-02-11

No results posted yet for this study

Summary

Major trauma frequently occurs in the deployed, combat setting and is especially applicable in the recent conflicts with explosives dominating the combat wounded. In future near-peer conflicts we will likely face even more profound weapons including mortars and artillery. As such, the number of severely wounded will likely increase. Hypocalcemia frequently occurs after blood transfusions secondary to the preservatives in the blood products, however, recent data suggests that major trauma in and of itself is a risk factor for hypocalcemia. Calcium is a major ion involved in heart contractility and thus hypocalcemia can lead to poor contractility. Smaller studies have linked hypocalcemia to worse outcomes, but it remains unclear what causes hypocalcemia and if intervening could potentially save lives. We are seeking to address the following scientific questions, (1) Is hypocalcemia present following traumatic injury prior to transfusion during resuscitation? (2) Does hypocalcemia influence the amount of blood products transfused? (3) To what extent is hypocalcemia further exacerbated by transfusion? (4) What is the relationship between hypocalcemia following traumatic injury and mortality? The investigators will conduct a multicenter, prospective, observational study. The investigators will gather ionized calcium levels at 0, 3, 6, 12, 18, and 24 hours as part of scheduled calcium measurements. This will ensure that the investigators have accurate data to assess the early and late effects of hypocalcemia throughout the course of resuscitation and hemorrhage control. These data will be captured by a trained study team personnel at every site. Our findings will inform clinical practice guidelines and optimize the care delivered in the combat and civilian trauma setting.

Conditions

Interventions

DIAGNOSTIC_TEST

Amending current standard trauma order set

Blood draw happens as part of routine clinical care for all trauma activations. As part of the study, we will use existing blood that is drawn as part of routine clinical care, or when necessary, draw additional blood to obtain samples at 0, 3, 6, 12, 18, and 24 hours assessing ionized calcium, serum calcium, and magnesium. We will strive to have draws occur within +/- 1 hour of the goal times. However, given that the blood draws will be performed by way of the clinical team and the unpredictable nature of trauma care, missed draws or draws out of the goal time frame will not be considered protocol violations

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • The University of Texas Health Science Center at San Antonio

    collaborator OTHER

  • Brooke Army Medical Center

    lead FED

Principal Investigators

  • Steven G Schauer, D.O. · U.S. Army Institute of Surgical Research

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2024-03-30
Completion
2025-06-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05885256 on ClinicalTrials.gov