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Clinical Trials/NCT06136715
NCT06136715
Recruiting
Not Applicable

Massive Transfusion in Trauma Patient Registry

Methodist Health System1 site in 1 country500 target enrollmentJuly 13, 2023
ConditionsTrauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trauma
Sponsor
Methodist Health System
Enrollment
500
Locations
1
Primary Endpoint
Establish a data set that will be permissive of quality improvement studies/observations specific to MTP in the trauma patient.
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The early use of blood products as a part of Massive Transfusion Protocol (MTP) during trauma resuscitation has been increasingly supported by providers and backed by the literature. However, the incidence of hypocalcemia during MTP has also been recorded and continues to be studied as an exacerbating factor in coagulopathy during trauma.

Detailed Description

Although initially it was thought that the coagulopathy was due to the trauma itself, studies suggest that it is worsened by the transfusion of blood as this is associated with increased hypocalcemia. The level of hypocalcemia is said to correlate with the amount of blood products transfused, but the number of units needed to produce a particular degree of hypocalcemia remains to be defined. A standardized value for hypocalcemia due to MTP has yet to be established. Establishing this value would be helpful in determining what level actually affects the rate of mortality. Some studies suggest intravenous calcium supplement should be considered during massive transfusion while others state this does not make a difference. This data repository will serve as a means to aggregate and analyze best practices as relative to MTP in the trauma patient, with specific interest in component best practices, whole blood protocols, and electrolyte/metabolite replacement.

Registry
clinicaltrials.gov
Start Date
July 13, 2023
End Date
July 13, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • • ≥18 years old
  • Included in the Methodist dallas medical center(MDMC) trauma registry
  • Flagged for MTP activation and/or \>1unit(U) blood product recorded in the first 24 hours

Exclusion Criteria

  • • \<18 years old

Outcomes

Primary Outcomes

Establish a data set that will be permissive of quality improvement studies/observations specific to MTP in the trauma patient.

Time Frame: 5 YEARS

This data repository will serve as a means to aggregate and analyze best practices as relative to MTP in the trauma patient, with specific interest in component best practices, whole blood protocols, and electrolyte/metabolite replacement.

Study Sites (1)

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