N/A
Completed N=254
Frozen Red Blood Cell Transfusions in Trauma Patients
Source: ClinicalTrials.gov NCT01038557 ↗Enrolled (actual)
254
Serious AEs
7.5%
Results posted
Jan 2020
Primary outcomePrimary: Tissue Oxygenation — 100.3; 98.2; 98.3 percentage of baseline
Summary
The purpose of this study is to look at red blood cell (RBC) transfusions in trauma patients and evaluate for any differences between the age of the RBCs and how they were stored. The investigators will specifically look for the following differences between study groups:
1. the transfused red blood cells' ability to delivery oxygen to the tissues
2. differences in biochemical markers in subjects and units transfused, and
3. how the subject's internal organs are working and if they develop any infections
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tissue Oxygenation |
100.3; 98.2; 98.3 | — |
| SECONDARY 2,3 DPG Levels After Transfusion |
0.33; 0.36; 0.31 | — |
| SECONDARY Free Hemoglobin Levels After Transfusion |
201; 194; 174 | — |
| SECONDARY Haptoglobin Levels 12 Hours After Transfusion |
897; 1470; 1350 | — |
| SECONDARY Clinical Outcomes - Hospital Days |
13; 13.5; 18 | — |
| SECONDARY Clinical Outcomes - ICU Days |
6; 5; 7 | — |
| SECONDARY Clinical Outcomes - Ventilator Days |
0; 0; 1 | — |
| SECONDARY Number of Participants With Acute Renal Failure |
7; 7; 10 | — |
| SECONDARY Clinical Outcomes - Acute Respiratory Distress Syndrome |
5; 2; 4 | — |
| SECONDARY Clinical Outcomes - Infections |
24; 22; 24 | — |
Eligibility Criteria
Inclusion Criteria
- Trauma Service with an Injury Severity Score > 4
- Require a blood (PRBC) transfusion
- Transfusion is not emergent
- Able to obtain consent from patient or appropriate 3rd party prior to 1st transfusion
Exclusion Criteria
- Inability to adhere to blood age randomization due to limitations of the blood bank inventory
- Bilateral hand injuries that prevent StO2 measurements
- Age 10 units in 24 hours) in last 3 months
- Hemodynamically unstable or need for transfusion in < 3 hours
Data sourced from ClinicalTrials.gov (NCT01038557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.