Blood Storage Related Mortality and Adverse Effects in Trauma Patients

NCT07341139 | Recruiting

• 1 other identifier: AS-Blood
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this retrospective study is to examine the following factors related to blood storage time in severely injured trauma patients who received large blood transfusions:

1. 1.The effect of blood storage time on the patient's 28-day mortality rate.
2. 2.The relationship between storage time and other health problems that the patient may develop (such as heart disease, vascular occlusion, respiratory failure, infection, and organ failure).

Conditions

Major Trauma; Transfusion Adverse Reaction; Blood Product Transfusion for All Conditions

Keywords

blood storage; Transfusion; Trauma; Red Blood Cell

Outcome Measures

Primary Outcomes (1)

• 28-day Mortality

  The aim of this study was to evaluate the effect of red blood cell and whole blood storage duration on 28-day mortality in severely injured trauma patients (injury severity score \>15) undergoing massive transfusion.

  At the day of 28 after massive blood transfusion

Secondary Outcomes (5)

• 28-day Morbidity - Cardiac Ischemia

  At the day of 28 after massive blood transfusion

• 28-day morbidity- thromboembolic events

  At the day of 28 after massive blood transfusion

• 28-day morbidity- nosocomial infection

  At the day of 28 after massive blood transfusion

• 28-day morbidity- multiple organ failure

  At the day of 28 after massive blood transfusion

• 28-day morbidity- acute respiratory failure

  At the day of 28 after massive blood transfusion

Study Arms (1)

Group 1

The study will include patients aged 18-75, with an ISS \>15, who presented directly from the injury scene and received massive transfusion (defined as \>10 packed RBC (PRBC) units in the first 24 hours or ≥3 units in 1 hour) between January 1, 2023, and October 1, 2025. Data will be extracted from hospital information systems and anesthesia records. The storage duration for each transfused unit (from collection to transfusion) will be recorded.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In our study, patients between the ages of 18-75, directly from the scene of injury, ISS\>15 and who received massive blood transfusion (\>10 packed RBC units in the first 24 hours, with an alternative definition of greater than or equal to 3 packed RBC units transfused in 1 hour) will be included in the study at University of Florida Jacksonville Shands Hospital between the dates 1 January 2023 to 1 31 December 2025.

You may qualify if:

• Patients between 18-75 years of age,
• Injury Severity Score\>15 and have received massive blood transfusions in our hospital from 1 January 2015 to 31 December 2025
• The patients admitted because of trauma and undergoing surgery

You may not qualify if:

• Patients with known cardiac or vascular diseases such as heart failure or malignant hypertension, those under anticoagulant treatment
• Patients with known serious kidney (on dialysis), lung, liver diseases, those under anticoagulant treatment
• Super obese patients with body mass index (BMI) 50 or above

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

UF Health Jacksonville (Shands Hospital)

Jacksonville, Florida, 32209, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• ayten saracoglu

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ayten saracoglu, prof dr

CONTACT

+1 (904) 5245932; anesthesiayten@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 14, 2026
• Study Start: January 17, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (1)