Trends in Transfusion Strategies and Outcomes in Trauma

May 17, 2026 updated by: Mariah Arif

Temporal Trends in Transfusion Strategies and Outcomes in Trauma: A 5-Year Analysis From a Level I Trauma Center

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32611
        • University of Florida Health Trauma One Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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:

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

Description

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:

  1. Injury Severity Score (ISS) ≥16, or
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Whole blood
Patients who received whole blood
Not whole blood
Patients who did not receive whole blood and instead only blood components

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-hospital mortality
Time Frame: From date of hospital admission until date of death, assessed up to 60 months
From date of hospital admission until date of death, assessed up to 60 months
ICU length of stay
Time Frame: from date of ICU admission until date of ICU discharge, assessed up to 60 months
from date of ICU admission until date of ICU discharge, assessed up to 60 months
Hospital length of stay
Time Frame: from admission till discharge or death
from admission till discharge or death
Ventilator-free days
Time Frame: Within 28 days post-ventilator use
Within 28 days post-ventilator use
Acute kidney injury
Time Frame: Increase in serum creatinine by ≥0.3 mg/dL within 48 hours, or Increase in serum creatinine to ≥1.5 times baseline within 7 days, or Urine output <0.5 mL/kg/hour for 6 hours.
Increase in serum creatinine by ≥0.3 mg/dL within 48 hours, or Increase in serum creatinine to ≥1.5 times baseline within 7 days, or Urine output <0.5 mL/kg/hour for 6 hours.
thromboembolic events
Time Frame: from date of admission up till date of discharge, assessed up to 60 months
deep vein thrombosis, pulmonary embolism, stroke
from date of admission up till date of discharge, assessed up to 60 months
Number of participants with multiorgan failure
Time Frame: From date of hospital admission until date of documented organ failure, assessed unto 60 months
Multiorgan failure (MOF) was defined as dysfunction or failure of two or more organ systems as assessed by the Sequential Organ Failure Assessment (SOFA) score.
From date of hospital admission until date of documented organ failure, assessed unto 60 months
Transfusion related complications
Time Frame: Within 6 hours of transfusion
Transfusion related acute lung injury, Transfusion associated circulatory overload
Within 6 hours of transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: ayten saracoglu, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 17, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IRB202600226

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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