NCT06136715

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2025

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

November 13, 2023

Last Update Submit

January 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • ≥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

You may not qualify if:

  • \<18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Conner McDaniel, MD

    Methodist Midlothian Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bethany Brauer, MPH

CONTACT

Colette Ngo Ndjom, MS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

July 13, 2023

Primary Completion

July 13, 2024

Study Completion

July 13, 2025

Last Updated

January 18, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
2 years

Locations