Trends in Transfusion Strategies and Outcomes in Trauma

NCT07603999 | Completed

• 1 other identifier: IRB202600226
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Transfusion; Trauma Coagulopathy; Mortality; Blood Transfusion

Outcome Measures

Primary Outcomes (1)

• 30-day all cause mortality

  30 days post-transfusion

Secondary Outcomes (8)

• 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

• Hospital length of stay

  from admission till discharge or death

• Ventilator-free days

  Within 28 days post-ventilator use

• Acute kidney injury

  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.

Study Arms (2)

Whole blood

Patients who received whole blood

Not whole blood

Patients who did not receive whole blood and instead only blood components

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mariah Arif: lead

Study Sites (1)

University of Florida Health Trauma One Center

Gainesville, Florida, 32611, United States

Location

Study Officials

• Ayten Saracoglu

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 22, 2026
• Study Start: January 1, 2020
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)