Transfusion Adverse ReactionNCT07341139
Blood Storage Related Mortality and Adverse Effects in Trauma Patients
An observational study of Transfusion Adverse Reaction and Major Trauma, run by Kocaeli City Hospital at 1 site in United States.
Trial 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. The effect of blood storage time on the patient's 28-day mortality rate. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Transfusion Adverse Reaction, Major Trauma, Blood Product Transfusion for All Conditions
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2026to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health Jacksonville (Shands Hospital)
Jacksonville, Florida, 32209
About this study
Official title: Is Long-Term Blood Storage Related With Increased Mortality and Adverse Effects in Severely Injured Trauma Patients?
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:
- The effect of blood storage time on the patient's 28-day mortality rate.
- 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).
For this purpose, patients aged 18-75 who were admitted directly from the scene of injury and received large transfusions at Jacksonville Shands Hospital between January 1, 2023, and October 1, 2025, will be included. Data will be obtained from hospital information systems and anesthesia records
Read the detailed description
Is Long-Term Blood Storage related with increased mortality and adverse effects in severely injured trauma patients?
Abstract
Background: Severe trauma remains a significant cause of mortality, often necessitating massive transfusion. During storage, red blood cells (RBCs) and whole blood units develop "storage lesions," encompassing biochemical and structural deteriorations such as oxidative damage to hemoglobin, metabolic derangements (e.g., lactate accumulation, adenosine triphosphate (ATP) and 2,3-diphosphoglycerate (2,3-DPG) depletion), and increased vesiculation. These changes are hypothesized to contribute to adverse clinical outcomes, including impaired microvascular perfusion, endothelial injury, hypercoagulability, inflammation, multi-organ dysfunction, and increased mortality. While numerous observational studies and meta-analyses suggest an association between prolonged blood storage duration and worse outcomes, large randomized controlled trials (RCTs) have yielded conflicting results. The impact of storage age on high-risk trauma patients requiring massive transfusion remains particularly uncertain.
Objective: This study aims to evaluate the effect of RBC and whole blood storage duration on 28-day mortality in severely injured trauma patients (Injury Severity Score (ISS) >15) undergoing massive transfusion. A secondary objective is to assess the relationship between storage duration and morbidity, including complications such as cardiac ischemia, thromboembolic events, acute respiratory failure, nosocomial infection, and multiple organ failure.
Methods: A single-center retrospective cohort study will be conducted at the University of Florida Jacksonville Shands Hospital. 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. Blood products are preserved with Adsol AS-1 additive solution, allowing storage of packed RBCs for 42 days and whole blood for 21 days.
Patients will be analyzed based on the product type (PRBCs vs. whole blood) and stratified into storage duration groups: Group 1 (0-7 days), Group 2 (8-14 days), Group 3 (15-21 days), and Group 4 (≥22 days, for PRBCs only). Comprehensive data will be collected, including demographics, injury mechanism, physiological parameters (vital signs, blood gas analyses including lactate, HCO₃, Hb, pH), laboratory values (e.g., creatinine), transfusion volumes (RBC, fresh frozen plasma (FFP), platelets, cryoprecipitate), fluid administration, urine output, vasopressor requirements, and perioperative complications. Outcomes of interest are 28-day mortality, morbidity endpoints, and lengths of intensive care unit (ICU) and hospital stay.
Statistical Analysis: Statistical analyses will be performed using R software. Descriptive statistics will summarize the data. Normality will be assessed using the Shapiro-Wilk test. Group comparisons will utilize t-tests, Mann-Whitney U tests, ANOVA, or Wilcoxon tests as appropriate. Categorical data will be compared using Pearson's chi-square or Fisher's exact tests. Correlations will be assessed via Spearman's analysis. Linear and logistic regression models will identify factors influencing continuous outcomes (e.g., ICU stay) and binary outcomes (e.g., mortality, complications), respectively. Survival analysis will employ Kaplan-Meier curves and the Log-Rank test. A p-value <0.05 will be considered statistically significant.
Conclusion: This retrospective cohort study seeks to clarify the contentious relationship between the age of transfused blood and clinical outcomes in a high-risk population of major trauma patients requiring massive transfusion. By specifically focusing on this vulnerable group and employing detailed stratification of storage duration, the study aims to provide evidence on whether the transfusion of older blood units is associated with increased 28-day mortality and higher morbidity. The findings could inform blood bank inventory management and transfusion practices in trauma resuscitation.
- Keywords
- blood storage, Transfusion, Trauma, Red Blood Cell
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the day of 28 after massive blood transfusion
Secondary outcomes (5)
28-day Morbidity - Cardiac Ischemia
On the 28th day after the blood transfusion, patients will be assessed for cardiac ischemia.
Measured: At the day of 28 after massive blood transfusion
28-day morbidity- thromboembolic events
On the 28th day after the blood transfusion, patients will be assessed for thromboembolic events,
Measured: At the day of 28 after massive blood transfusion
28-day morbidity- nosocomial infection
On the 28th day after the blood transfusion, patients will be assessed for nosocomial infection,
Measured: At the day of 28 after massive blood transfusion
28-day morbidity- multiple organ failure
On the 28th day after the blood transfusion, patients will be assessed for multiple organ failure.
Measured: At the day of 28 after massive blood transfusion
28-day morbidity- acute respiratory failure
On the 28th day after the blood transfusion, patients will be assessed for acute respiratory failure
Measured: At the day of 28 after massive blood transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start17 Jan 2026
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ayten saracoglu, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341139
- Sponsor's protocol ID
- AS-Blood
- Status last verified
- Aug 2026
- First submitted
- 17 Dec 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Long-Term Blood Storage Related With Increased Mortality and Adverse Effects in Severely Injured Trauma Patients?
- ClinicalTrials.gov ID
- NCT07341139
- Acronym / sponsor ID
- AS-Blood
- Keywords
- blood storage, Transfusion, Trauma, Red Blood Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 17 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The effect of blood storage time on the patient's 28-day mortality rate.
- 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).
For this purpose, patients aged 18-75 who were admitted directly from the scene of injury and received large transfusions at Jacksonville Shands Hospital between January 1, 2023, and October 1, 2025, will be included. Data will be obtained from hospital information systems and anesthesia records
Detailed description
Is Long-Term Blood Storage related with increased mortality and adverse effects in severely injured trauma patients?
Abstract
Background: Severe trauma remains a significant cause of mortality, often necessitating massive transfusion. During storage, red blood cells (RBCs) and whole blood units develop "storage lesions," encompassing biochemical and structural deteriorations such as oxidative damage to hemoglobin, metabolic derangements (e.g., lactate accumulation, adenosine triphosphate (ATP) and 2,3-diphosphoglycerate (2,3-DPG) depletion), and increased vesiculation. These changes are hypothesized to contribute to adverse clinical outcomes, including impaired microvascular perfusion, endothelial injury, hypercoagulability, inflammation, multi-organ dysfunction, and increased mortality. While numerous observational studies and meta-analyses suggest an association between prolonged blood storage duration and worse outcomes, large randomized controlled trials (RCTs) have yielded conflicting results. The impact of storage age on high-risk trauma patients requiring massive transfusion remains particularly uncertain.
Objective: This study aims to evaluate the effect of RBC and whole blood storage duration on 28-day mortality in severely injured trauma patients (Injury Severity Score (ISS) >15) undergoing massive transfusion. A secondary objective is to assess the relationship between storage duration and morbidity, including complications such as cardiac ischemia, thromboembolic events, acute respiratory failure, nosocomial infection, and multiple organ failure.
Methods: A single-center retrospective cohort study will be conducted at the University of Florida Jacksonville Shands Hospital. 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. Blood products are preserved with Adsol AS-1 additive solution, allowing storage of packed RBCs for 42 days and whole blood for 21 days.
Patients will be analyzed based on the product type (PRBCs vs. whole blood) and stratified into storage duration groups: Group 1 (0-7 days), Group 2 (8-14 days), Group 3 (15-21 days), and Group 4 (≥22 days, for PRBCs only). Comprehensive data will be collected, including demographics, injury mechanism, physiological parameters (vital signs, blood gas analyses including lactate, HCO₃, Hb, pH), laboratory values (e.g., creatinine), transfusion volumes (RBC, fresh frozen plasma (FFP), platelets, cryoprecipitate), fluid administration, urine output, vasopressor requirements, and perioperative complications. Outcomes of interest are 28-day mortality, morbidity endpoints, and lengths of intensive care unit (ICU) and hospital stay.
Statistical Analysis: Statistical analyses will be performed using R software. Descriptive statistics will summarize the data. Normality will be assessed using the Shapiro-Wilk test. Group comparisons will utilize t-tests, Mann-Whitney U tests, ANOVA, or Wilcoxon tests as appropriate. Categorical data will be compared using Pearson's chi-square or Fisher's exact tests. Correlations will be assessed via Spearman's analysis. Linear and logistic regression models will identify factors influencing continuous outcomes (e.g., ICU stay) and binary outcomes (e.g., mortality, complications), respectively. Survival analysis will employ Kaplan-Meier curves and the Log-Rank test. A p-value <0.05 will be considered statistically significant.
Conclusion: This retrospective cohort study seeks to clarify the contentious relationship between the age of transfused blood and clinical outcomes in a high-risk population of major trauma patients requiring massive transfusion. By specifically focusing on this vulnerable group and employing detailed stratification of storage duration, the study aims to provide evidence on whether the transfusion of older blood units is associated with increased 28-day mortality and higher morbidity. The findings could inform blood bank inventory management and transfusion practices in trauma resuscitation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
28-day Mortality
Time frame: At the day of 28 after massive blood transfusion
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.
5 secondary outcomes
28-day Morbidity - Cardiac Ischemia
Time frame: At the day of 28 after massive blood transfusion
28-day morbidity- thromboembolic events
Time frame: At the day of 28 after massive blood transfusion
28-day morbidity- nosocomial infection
Time frame: At the day of 28 after massive blood transfusion
28-day morbidity- multiple organ failure
Time frame: At the day of 28 after massive blood transfusion
28-day morbidity- acute respiratory failure
Time frame: At the day of 28 after massive blood transfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ayten saracoglu principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transfusion Adverse Reaction and Major Trauma, run by Kocaeli City Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day Mortality (time frame: At the day of 28 after massive blood transfusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.