Massive Transfusion in Trauma Patient Registry

NCT ID: NCT06136715

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-13

Study Completion Date

2025-07-13

Brief Summary

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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

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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.

Conditions

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Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Conner McDaniel, MD

Role: PRINCIPAL_INVESTIGATOR

Methodist Midlothian Medical Center

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bethany Brauer, MPH

Role: CONTACT

214-947-4681

Colette Ngo Ndjom, MS

Role: CONTACT

214-947-4681

Facility Contacts

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Bethany Brauer, MPH

Role: primary

214-947-4681

Colette Ngo Ndjom, MS

Role: backup

217-947-4681

Other Identifiers

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029.TRA.2023.D

Identifier Type: -

Identifier Source: org_study_id

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