Trends in Transfusion Strategies and Outcomes in Trauma | NCT07603999

Studies
Trends in Transfusion Strategies and Outcomes in Trauma

NCT07603999

Sponsor

Mariah Arif

Status

Completed

Last Update Posted

May 22, 2026Actual

Enrollment

137Actual

Phase

Not provided

Conditions

Transfusion
Trauma Coagulopathy
Mortality
Blood Transfusion

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

May 8, 2026

First Submission Date that Met QC Criteria

May 17, 2026

First Posted Date

May 22, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This retrospective cohort study evaluated transfusion practices and outcomes in 137 severely injured trauma patients requiring massive transfusion at a Level I trauma center (2020-2025). This study analyzed balanced transfusion ratios, whole blood (WB) use, thromboelastography (TEG), and adjunctive hemostatic therapies to determine their impact on 30-day mortality and other clinical outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

137Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Whole blood		Patients who received whole blood
Not whole blood		Patients who did not receive whole blood and instead only blood components

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30-day all cause mortality		30 days post-transfusion

Secondary Outcomes

Measure	Description	Time Frame
in-hospital mortality		From date of hospital admission until date of death, assessed up to 60 months
ICU length of stay		from date of ICU admission until date of ICU discharge, assessed up to 60 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult trauma patients (≥18 years) presenting directly to the trauma center were eligible for inclusion if they met at least one of the following criteria:

Injury Severity Score (ISS) ≥16, or
requirement for massive transfusion, defined as >10 units of packed red blood cells (PRBC) within the first 24 hours.

Exclusion Criteria:

Death on arrival,
Transfer from external institutions after initial resuscitation
Incomplete transfusion or outcome data
Significant pre-existing comorbidities (including advanced heart failure, end-stage renal disease, cirrhosis with portal hypertension, chronic oxygen dependence, or non-reversible anticoagulation therapy).
Patients with isolated minor injuries not requiring trauma team activation were also excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult trauma patients (≥18 years) presenting directly to the trauma center were eligible for inclusion if they met at least one of the following criteria:

Injury Severity Score (ISS) ≥16, or
requirement for massive transfusion, defined as >10 units of packed red blood cells (PRBC) within the first 24 hours.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayten Saracoglu	University of Florida	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida Health Trauma One Center		Gainesville	Florida	32611	United States