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Clinical Assessment of Low Calcium In traUMa (CALCIUM)

Study acronym: CALCIUM
StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv3
  2. Minor Trial status: Recruiting to Active, Not Recruitingv2 Show 4 more changesShow less
    • Primary completion date changed from estimate of Jan 30, 2024 to Mar 30, 2024
    • Study completion date: Jan 30, 2024 to Jun 30, 2025
    • Study description expanded, about 19 words
    • Site details revised
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05885256
Lead Sponsor Brooke Army Medical Center
Collaborators: University of Colorado, Denver, The University of Texas Health Science Center at San Antonio
Conditions
(from sponsor)
Hypocalcemia
Related terms Emergencies, Hypocalcemia, Wounds and Injuries
Enrollment 391 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov