- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07603999
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
Status
Completed
Conditions
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:
- 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.
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:
- 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.
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.