Massive Transfusion in Trauma Patient Registry

Trauma Clinical Trial

Official title:

Massive Transfusion in Trauma Patient Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136715
• Other study ID #: 029.TRA.2023.D
• Status: Recruiting
• Start date: July 13, 2023
• Est. completion date: July 13, 2025

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: Bethany Brauer, MPH
• Phone: 214-947-4681
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 13, 2025
• Est. primary completion date: July 13, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Behavioral:
• blood products as a part of Massive Transfusion Protocol
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

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish a data set that will be permissive of quality improvement studies/observations specific to MTP in the trauma patient.	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.	5 YEARS