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Massive Transfusion in Trauma Patient Registry

Massive Transfusion in Trauma Patient Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06136715
Enrollment
500
Registered
2023-11-18
Start date
2023-07-13
Completion date
2025-07-13
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

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.

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.

Interventions

BEHAVIORALblood 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

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Establish a data set that will be permissive of quality improvement studies/observations specific to MTP in the trauma patient.5 YEARSThis 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.

Countries

United States

Contacts

Primary ContactBethany Brauer, MPH
MHSIRB@mhd.com214-947-4681
Backup ContactColette Ngo Ndjom, MS
mhsirb@mhd.com214-947-4681

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026