TransfusionNCT07603999
Trends in Transfusion Strategies and Outcomes in Trauma
An observational study of Transfusion and Trauma Coagulopathy, run by Mariah Arif at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfusion, Trauma Coagulopathy, Mortality
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Health Trauma One Center
Gainesville, Florida, 32611
About this study
Official title: 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.
- Conditions
- Transfusion, Trauma Coagulopathy, Mortality, Blood Transfusion
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 |
|---|---|---|
| Whole blood | Patients who received whole blood | |
| Not whole blood | Patients who did not receive whole blood and instead only blood components |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all cause mortality
Measured: 30 days post-transfusion
Secondary outcomes (8)
in-hospital mortality
Measured: From date of hospital admission until date of death, assessed up to 60 months
ICU length of stay
Measured: from date of ICU admission until date of ICU discharge, assessed up to 60 months
Hospital length of stay
Measured: from admission till discharge or death
Ventilator-free days
Measured: Within 28 days post-ventilator use
Acute kidney injury
Measured: 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
deep vein thrombosis, pulmonary embolism, stroke
Measured: from date of admission up till date of discharge, assessed up to 60 months
Number of participants with multiorgan failure
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.
Measured: From date of hospital admission until date of documented organ failure, assessed unto 60 months
Transfusion related complications
Transfusion related acute lung injury, Transfusion associated circulatory overload
Measured: Within 6 hours of transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransfusionStudies 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
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mariah Arif
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Mariah Arif, Hamad General Hospital
- Investigators
- Ayten Saracoglu, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603999
- Sponsor's protocol ID
- IRB202600226
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 22 May 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 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Trends in Transfusion Strategies and Outcomes in Trauma: A 5-Year Analysis From a Level I Trauma Center
- ClinicalTrials.gov ID
- NCT07603999
- Acronym / sponsor ID
- IRB202600226
- Conditions
- Transfusion, Trauma Coagulopathy, Mortality, Blood Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Mariah ArifOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 22 May 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole blood | – | –Patients who received whole blood |
| Not whole blood | – | –Patients who did not receive whole blood and instead only blood components |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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
30-day all cause mortality
Time frame: 30 days post-transfusion
8 secondary outcomes
in-hospital mortality
Time frame: 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
Hospital length of stay
Time frame: from admission till discharge or death
Ventilator-free days
Time frame: 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.
thromboembolic events
Time frame: 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
Transfusion related complications
Time frame: Within 6 hours of 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 22 May 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 and Trauma Coagulopathy, run by Mariah Arif 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 5 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 22 May 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?
30-day all cause mortality (time frame: 30 days post-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 22 May 2026.