Hypocalcemia Clinical Trial
— CALCIUMOfficial title:
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 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.
Status | Recruiting |
Enrollment | 391 |
Est. completion date | January 30, 2024 |
Est. primary completion date | January 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Brooke Army Medical Center | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center | The University of Texas Health Science Center at San Antonio, University of Colorado, Denver |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Additional Lab blood Draw Sample | Obtain blood samples at 0, 3, 6, 12, 18, and 24 hours | 24 hours |
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