Clinical Assessment of Low Calcium In traUMa (CALCIUM) (CALCIUM)

May 23, 2023 updated by: Steven Schauer, Brooke Army Medical Center
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? We will conduct a multicenter, prospective, observational study. We will gather ionized calcium levels at 0, 3, 6, 12, 18, and 24 hours as part of scheduled calcium measurements. This will ensure that we 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES/SPECIFIC AIMS/RESEARCH QUESTIONS

We will determine the incidence of hypocalcemia on hospital arrival and the association with survival.

Aim 1: Overall incidence of hypocalcemia on ED arrival in major trauma patients Aim 2: Association of hypocalcemia with severity of hemorrhage Aim 3: Association of hypocalcemia with the number of blood products transfused and supplemental calcium administration Aim 4: The association of hypocalcemia with early and 24-hour mortality.

RESEARCH PLAN

Research Design We will conduct a prospective, multicenter, observational study.

Subject Population(s)

Trauma patients that are brought in as a trauma activation will be sought. Number of Subjects, Records, and/or Specimens- Approximately 391

Inclusion Criteria 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 Exclusion Criteria We will exclude patients that are known or suspected to be pregnant, less than , or prisoner status.

Research Procedures

1. Identification of Trauma Subjects (BAMC)

Trauma patients for enrollment in the study will be identified using our trauma activation protocols in the emergency department. The decision to use trauma team activations will be solely at the discretion of the clinical team. All trauma patients coming in the emergency department that meet criteria for trauma activation will be potential subjects for capture in the study. We will enroll a generally continuous sample by amending our current standard trauma order set which currently requires the following tubes be drawn on every trauma activation upon arrival:

1 green top (ionized calcium source)

lavender top blue tops 1 pink top

1 red top

1 blood gas tube

1 TEG tube

In addition to the order set change, we will promote capture by way of staff education, staff reminders, staff-facing signage, and dissemination via routine department communications.

2. Obtaining Trauma Subject Blood Samples (BAMC) All patients coming in as part of trauma activations have a standard blood panel order set that is placed as outlined above. 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.

3. Storage of the Blood Samples (BAMC) The tubes of blood will be handled per the current standard operating procedures (SOP). The lab studies will be done based on the institutional equipment requirements and SOPs. No banking or repository of blood samples is planned for this study so all specimen storage and destruction will be based on the laboratory SOPs.

4. Data Extraction

Data extraction will occur via three methods:

A study team member will perform manual data extraction by way of medical records review, and/or a study team member will submit the patient information along with the approved data extraction variable list to the designed point of contact within the information management division (IMD) for EMR data repository data extraction, and/or a study team member will submit the patient information along with the approved data extraction variable list to the designed point of contact within the local trauma registry team.

5. Data Aggregation Data will be aggregated by a study team member into a local database. The data will be stored locally along with the master key that links all the data back to the patients in the event additional data is needed or data verification is required. De-identified data will be uploaded to the aggregate data within REDCap which will allow for aggregation among all the sites.

Data Collection

The blood draws will occur via the clinical staff. The current order set has blood draws at a minimum of every 6 hours (0, 6, 12, 18, 24). Additional lab studies are likely to be added based on how critical the patient. We will modify the order set to include blood draws at 0, 3, 6, 12, 18, 24. We will need a green top tube for the ionized calcium which is <5mL per tube and the drawn tube will have multiple uses (e.g. metabolic panels, alcohol levels, etc.). Additional ionized calcium studies may be ordered solely at the discretion of the attending clinician and will be included in the analysis. . With regards to the clinical data, we plan to capture the data after clinical care has occurred and includes the following:

Demographics Injury Severity Scores Timing- date and time of injury, EMS arrival time, air transport arrival time, transferring center arrival time, trauma center arrival time Blood products infusion Laboratory Studies Medications Procedures Vital Signs Prehospital Medications Hospital Medications Imaging Studies Blood products and fluids Outcome data- discharge status, time to death, ventilator days, intensive care unit days, hospital days, discharge location, total blood products and fluids received, cardiac events Data analysis

We will primarily use descriptive and inferential statistics along with regression modeling. Significance for results will be established when p-values are less than 0.05. Categorical Data will be summarized using percentages and Chi-Squared tests or Fisher's exact test where appropriate. Means and standard deviations or medians and interquartile ranges will be used as summary statistics for continuous variables, and they will be analyzed using Student's t-test and ANOVA or Wilcoxon's Test where appropriate. Data may be log-transformed for normalization. We will use Discrete-Time (eg. Complementary Log-Log) or Cox Proportional Hazards to assess associations between baseline and time-dependent covariates with time-to-hypocalcemia. Treatment variables, such as blood product transfusion, will be measured at time-dependent covariates. Cox Proportional Hazards models will be used to assess associations between baseline covariates, time-dependent covariates (treatments and hypocalcemia), and mortality. We will analyze data using relevant statistical software including SAS (v9.4, Cary, North Carolina), JMP Statistical Discovery (v15, Cary, North Carolina), Microsoft Excel (v360, Redmond, Washington).

Study Type

Observational

Enrollment (Estimated)

391

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Lab blood Draw Sample
Time Frame: 24 hours
Obtain blood samples at 0, 3, 6, 12, 18, and 24 hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Collaborators

University of Colorado, Denver
The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Steven G Schauer, D.O., U.S. army Institute of Surgical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

January 30, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-21-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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