Recruiting

Observational Study

Sponsor:

Methodist Health System

Code:

NCT06136715

Conditions

Trauma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

blood products as a part of Massive Transfusion Protocol

Study Details

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.

Conditions

Trauma

Study ID

NCT06136715

Start date

Jul 13, 2023

Status verified date

Jan, 2024

Completion date

Jul 13, 2025

Anticipated

Primary completion date

Jul 13, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • Establish a data set that will be permissive of quality improvement studies/observations specific to MTP in the trauma patient. [ Time Frame: 5 YEARS ]

Central Contacts and Locations

Central contacts

Bethany Brauer, MPH

214-947-4681MHSIRB@mhd.com

Colette Ngo Ndjom, MS

214-947-4681mhsirb@mhd.com

Locations

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

Bethany Brauer, MPH

214-947-4681mhsirb@mhd.com

Colette Ngo Ndjom, MS

217-947-4681mhsirb@mhd.com

Principal Investigator:

Conner McDaniel, MD

More Information

Sponsor

Methodist Health System

Last update posted

Jan 18, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Methodist Health System on 2024-01-18.