Massive Transfusion in Trauma Patient Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma
• Intervention / Treatment: Behavioral: blood products as a part of Massive Transfusion Protocol

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Colette Ngo Ndjom, MS; Phone Number: 214-947-4681; Email: mhsirb@mhd.com
• Study Contact Backup: Name: Bethany Brauer, MPH; Phone Number: 214-947-4681; Email: mhsirb@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Principal Investigator: Conner McDaniel, MD
      • Contact: Bethany Brauer, MPH; Phone Number: 214-947-4681; Email: mhsirb@mhd.com
      • Contact: Colette Ngo Ndjom, MS; Phone Number: 217-947-4681; Email: mhsirb@mhd.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

≥18 years old

• Included in the MDMC trauma registry
• Flagged for MTP activation and/or >1U blood product recorded in the first 24 hours

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Conner McDaniel, MD, Methodist Midlothian Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): July 13, 2024
• Study Completion (Estimated): July 13, 2025

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 029.TRA.2023.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data or any protected health information will not be shared with anyone that is not delegated to the study. The PI is committed to disseminate research results in a timely fashion. Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals
• IPD Sharing Time Frame: 2 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No