Clinical Assessment of Low Calcium In traUMa (CALCIUM)

NCT05885256 | Active Not Recruiting DMC

• 1 other identifier: H-21-034
• Study Type: observational
• Target: 391
• Locations: 1 country
• Sites: 1

Brief 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

Hypocalcemia

Keywords

Hypocalcemia; emergency department; trauma

Outcome Measures

Primary Outcomes (1)

• Additional Lab blood Draw Sample

  Obtain blood samples at 0, 3, 6, 12, 18, and 24 hours

  24 hours

Study Arms (1)

Trauma Patients

Seeking all patients that meets trauma activation criteria for the amendment of our order set. The participants existing blood from the routine clinical care blood draws will be used to obtain samples.

Diagnostic Test: Amending current standard trauma order set

Interventions

Amending current standard trauma order set DIAGNOSTIC_TEST

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

Trauma Patients

Eligibility Criteria

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

Study Population

Trauma patients that are brought in as a trauma activation will be sought.

You may qualify if:

• We will include any patient that meets trauma activation criteria for the amendment of our order set.
• 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.

Sponsors & Collaborators

• Brooke Army Medical Center: lead
• University of Colorado, Denver: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

Location

Related Publications (25)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

All patients coming in as part of trauma activations have a standard blood panel order set. Blood draw happens as part of routine clinical care for all trauma activations. As part of the study, the investigators 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. The investigators 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.

MeSH Terms

Conditions

Hypocalcemia; Emergencies; Wounds and Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Steven G Schauer, D.O.

  U.S. Army Institute of Surgical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 1, 2023
• Study Start: September 1, 2022
• Primary Completion: March 30, 2024
• Study Completion: June 30, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)