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NCT05885256 · ClinicalTrials.gov registry record
Clinical Assessment of Low Calcium In traUMa (CALCIUM)
A clinical trial of Hypocalcemia, sponsored by Brooke Army Medical Center.
- Active
- Registry status
- 391
- Enrollment target
- 1
- Study location
NCT05885256: Active study of Hypocalcemia, sponsored by Brooke Army Medical Center.
NCT05885256 is a study of Hypocalcemia that is active but no longer recruiting, run by Brooke Army Medical Center. The registered enrollment target is 391 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05885256, a study of Hypocalcemia, is active but no longer recruiting, sponsored by Brooke Army Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 391 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Obtain blood samples at 0, 3, 6, 12, 18, and 24 hours
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Amending current standard trauma order set
Study Locations (1)
Texas
- Brooke Army Medical Center - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 391 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2025-06-30 |
What the registry record for NCT05885256 still lists
NCT05885256 is an observational study that tracks outcomes without assigning an intervention. The registered 391 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Hypocalcemia appearing as the primary indexed condition, and to 1 intervention - of which Amending current standard trauma order set is the first listed.
NCT05885256 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05885256 about?
NCT05885256 is a clinical study titled "Clinical Assessment of Low Calcium In traUMa (CALCIUM)". 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 seve...
What is the current status of trial NCT05885256?
This trial is currently active not recruiting. The enrollment target is 391 participants. The study started on 2022-09-01. Estimated completion is 2025-06-30.
What conditions does trial NCT05885256 study?
This clinical trial studies the following conditions: Hypocalcemia.
What interventions are being tested in trial NCT05885256?
The interventions under investigation include: Amending current standard trauma order set (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05885256?
This trial is sponsored by Brooke Army Medical Center, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05885256 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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