Clinical Assessment of Low Calcium In traUMa (CALCIUM)

Running, not enrolling

Conditions studied: Hypocalcemia

In brief

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.

Key facts

Study ID

NCT05885256

Run by

Brooke Army Medical Center

People needed

391

Starts

2022-09-01

Expected to finish

2025-06-30

Last updated by the study team

2025-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• We will include any patient that meets trauma activation criteria for the amendment of our order set.
• However, for our primary outcome analysis we will use the following inclusion criteria based on the "major trauma" activation criteria at the primary site (BAMC):
• Penetrating trauma to the head, neck, torso, or extremities (proximal to the elbow/knee)
• Traumatic arrest or CPR at any time
• Glasgow Coma Scale of 9 or less or deteriorating from initial arrival
• Systolic blood pressure <100mmHg
• Respiratory rate <10 or >29
• Intubated or requiring airway assistance (e.g. bag-valve mask, etc.)
• Any blood administered prehospital
• Vasopressors administered
• Pulseless, degloved, crushed, or mangled extremity proximal to the wrist
• Evidence of arterial bleeding with or without tourniquet application
• Amputations proximal to the wrist/ankle
• Chest needle decompression or chest thoracostomy

You may not qualify if…

• We will exclude patients that are known or suspected to be pregnant, less than 18, or prisoner status.

Where it is running

• Brooke Army Medical Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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