Massive Transfusion in Trauma Patient Registry

Sponsor
Methodist Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT06136715
Collaborator
(none)
500
1
24
20.8

Study Details

Study Description

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.1

Condition or Disease Intervention/Treatment Phase
  • 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.2,3 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.4,5 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.4,6 Some studies suggest intravenous calcium supplement should be considered during massive transfusion while others state this does not make a difference.3

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Massive Transfusion in Trauma Patient Registry
Actual Study Start Date :
Jul 13, 2023
Anticipated Primary Completion Date :
Jul 13, 2024
Anticipated Study Completion Date :
Jul 13, 2025

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Methodist Dallas Medical Center Dallas Texas United States 75203

Sponsors and Collaborators

  • Methodist Health System

Investigators

  • Principal Investigator: Conner McDaniel, MD, Methodist Midlothian Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Methodist Health System
ClinicalTrials.gov Identifier:
NCT06136715
Other Study ID Numbers:
  • 029.TRA.2023.D
First Posted:
Nov 18, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023