CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 391 enrolled
Drug / intervention
Amending current standard trauma order setother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05885256
NCT05885256N/AActive

Clinical Assessment of Low Calcium In traUMa (CALCIUM)

Brooke Army Medical Center·observational·Posted Jun 1, 2023·Updated Feb 11, 2025

In Brief

An observational study evaluating Amending current standard trauma order set for Hypocalcemia. Active but no longer recruiting, targeting 391 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHypocalcemia
CountriesUnited States

Timeline

N/AActiveOverdue
2023202420252026
First PostedJun 1, 2023
Enrollment StartSep 1, 2022
Primary CompletionMar 30, 2024
Study CompletionJun 30, 2025
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 3.1 years ago

Interventions

Amending current standard trauma order setother

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