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Completed

NCT Number: NCT07603999

Trends in Transfusion Strategies and Outcomes in Trauma

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.

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Key information

Conditions

Transfusion Blood Transfusion Mortality Trauma Coagulopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida Health Trauma One Center

Gainesville, Florida, 32611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 30-day all cause mortality

    Time frame: 30 days post-transfusion

Secondary outcomes

  1. in-hospital mortality

    Time frame: From date of hospital admission until date of death, assessed up to 60 months

  2. ICU length of stay

    Time frame: from date of ICU admission until date of ICU discharge, assessed up to 60 months

  3. Hospital length of stay

    Time frame: from admission till discharge or death

  4. Ventilator-free days

    Time frame: Within 28 days post-ventilator use

  5. 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.

  6. thromboembolic events

    Time frame: from date of admission up till date of discharge, assessed up to 60 months

    deep vein thrombosis, pulmonary embolism, stroke

  7. 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.

  8. Transfusion related complications

    Time frame: Within 6 hours of transfusion

    Transfusion related acute lung injury, Transfusion associated circulatory overload

Sponsors and collaborators

Lead sponsor

Mariah Arif

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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