Anemia, Blood Loss, Trauma
Conditions
Keywords
frozen, red blood cells, transfusion, trauma
Brief 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
Interventions
BIOLOGICALRBC units
When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored.
Sponsors
United States Air Force
Armed Services Blood Program
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
15 Years to 100 Years
Healthy volunteers
No
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 \< 15 * Pregnancy * Massive transfusion (=/\> 10 units in 24 hours) in last 3 months * Hemodynamically unstable or need for transfusion in \< 3 hours
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Oxygenation | Percentage of baseline (3 hours post transfusion compared to baseline) | Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Free Hemoglobin Levels After Transfusion | 12 hours after transfusion | Free hemoglobin levels 12 hours after transfusion |
| Haptoglobin Levels 12 Hours After Transfusion | 12 hours after transfusion | Haptoglobin levels after transfusion |
| Clinical Outcomes - Hospital Days | from time of randomization through hospital discharged, assessed up to 6 months | Clinical outcomes - Number of days admitted to the hospital within a 6 month window. |
| Clinical Outcomes - ICU Days | from time of randomization through hospital discharged, assessed up to 6 months | Number of days admitted to the ICU during hospital admission |
| 2,3 DPG Levels After Transfusion | 12 hours post transfusion | 2,3 DPG levels 12 hours after transfusion |
| Number of Participants With Acute Renal Failure | from time of randomization through hospital discharged, assessed up to 6 months | Number of participants who developed acute renal failure while hospitalized. |
| Clinical Outcomes - Acute Respiratory Distress Syndrome | from time of randomization through hospital discharged, assessed up to 6 months | Number of subjects who developed acute respiratory distress syndrome while hospitalized. |
| Clinical Outcomes - Infections | from time of randomization through hospital discharged, assessed up to 6 months | Number of subjects who developed infections while hospitalized. |
| Clinical Outcomes - Ventilator Days | from time of randomization through hospital discharged, assessed up to 6 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Refrigerated RBCs 0-14 Days Old Standard, refrigerated RBC units stored up to 14 days
RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored. | 82 |
| Refrigerated RBCs 15-42 Days Old Standard, refrigerated RBC units stored 15-42 days
RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored. | 86 |
| Frozen RBCs RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215.
RBC units: When a transfusion is ordered, enrolled subjects will receive RBC units 1) up to 14 days old, 2) 14-42 days old, or 3) that are frozen when stored. | 86 |
| Total | 254 |
Baseline characteristics
| Characteristic | Refrigerated RBCs 0-14 Days Old | Refrigerated RBCs 15-42 Days Old | Frozen RBCs | Total |
|---|---|---|---|---|
| Age, Continuous | 52.3 years | 47.9 years | 49.3 years | 49.3 years |
| Injury Severity Score | 19 units on a scale (1 best to 75 worst) | 19 units on a scale (1 best to 75 worst) | 19 units on a scale (1 best to 75 worst) | 19 units on a scale (1 best to 75 worst) |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 82 participants | 86 participants | 86 participants | 254 participants |
| Sex: Female, Male Female | 32 Participants | 40 Participants | 29 Participants | 101 Participants |
| Sex: Female, Male Male | 50 Participants | 46 Participants | 57 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 82 | 3 / 86 | 3 / 86 |
| other Total, other adverse events | 24 / 82 | 22 / 85 | 24 / 86 |
| serious Total, serious adverse events | 5 / 82 | 6 / 86 | 8 / 86 |
Outcome results
Primary
Tissue Oxygenation
Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion.
Time frame: Percentage of baseline (3 hours post transfusion compared to baseline)
Population: Mean percent change in tissue oxygenation (StO2) over time is reported for subjects with continuous data. Data on subjects whose NIRS device fell off or there was discontinuity in recording were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Refrigerated RBCs 0-14 Days Old | Tissue Oxygenation | 100.3 percentage of baseline | Standard Deviation 7.2 |
| Refrigerated RBCs 15-42 Days Old | Tissue Oxygenation | 98.2 percentage of baseline | Standard Deviation 11.4 |
| Frozen RBCs | Tissue Oxygenation | 98.3 percentage of baseline | Standard Deviation 14.1 |
Secondary
2,3 DPG Levels After Transfusion
2,3 DPG levels 12 hours after transfusion
Time frame: 12 hours post transfusion
Population: Blood samples to measure 2,3 DPG levels could not be collected from all subjects 12 hours after transfusion or results were not measurable.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refrigerated RBCs 0-14 Days Old | 2,3 DPG Levels After Transfusion | 0.33 g/L |
| Refrigerated RBCs 15-42 Days Old | 2,3 DPG Levels After Transfusion | 0.36 g/L |
| Frozen RBCs | 2,3 DPG Levels After Transfusion | 0.31 g/L |
Secondary
Clinical Outcomes - Acute Respiratory Distress Syndrome
Number of subjects who developed acute respiratory distress syndrome while hospitalized.
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Refrigerated RBCs 0-14 Days Old | Clinical Outcomes - Acute Respiratory Distress Syndrome | 5 Participants |
| Refrigerated RBCs 15-42 Days Old | Clinical Outcomes - Acute Respiratory Distress Syndrome | 2 Participants |
| Frozen RBCs | Clinical Outcomes - Acute Respiratory Distress Syndrome | 4 Participants |
Secondary
Clinical Outcomes - Hospital Days
Clinical outcomes - Number of days admitted to the hospital within a 6 month window.
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refrigerated RBCs 0-14 Days Old | Clinical Outcomes - Hospital Days | 13 days |
| Refrigerated RBCs 15-42 Days Old | Clinical Outcomes - Hospital Days | 13.5 days |
| Frozen RBCs | Clinical Outcomes - Hospital Days | 18 days |
Secondary
Clinical Outcomes - ICU Days
Number of days admitted to the ICU during hospital admission
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refrigerated RBCs 0-14 Days Old | Clinical Outcomes - ICU Days | 6 days |
| Refrigerated RBCs 15-42 Days Old | Clinical Outcomes - ICU Days | 5 days |
| Frozen RBCs | Clinical Outcomes - ICU Days | 7 days |
Secondary
Clinical Outcomes - Infections
Number of subjects who developed infections while hospitalized.
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Refrigerated RBCs 0-14 Days Old | Clinical Outcomes - Infections | 24 Participants |
| Refrigerated RBCs 15-42 Days Old | Clinical Outcomes - Infections | 22 Participants |
| Frozen RBCs | Clinical Outcomes - Infections | 24 Participants |
Secondary
Clinical Outcomes - Ventilator Days
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refrigerated RBCs 0-14 Days Old | Clinical Outcomes - Ventilator Days | 0 days |
| Refrigerated RBCs 15-42 Days Old | Clinical Outcomes - Ventilator Days | 0 days |
| Frozen RBCs | Clinical Outcomes - Ventilator Days | 1 days |
Secondary
Free Hemoglobin Levels After Transfusion
Free hemoglobin levels 12 hours after transfusion
Time frame: 12 hours after transfusion
Population: Blood samples to measure free hemoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refrigerated RBCs 0-14 Days Old | Free Hemoglobin Levels After Transfusion | 201 ug/mL |
| Refrigerated RBCs 15-42 Days Old | Free Hemoglobin Levels After Transfusion | 194 ug/mL |
| Frozen RBCs | Free Hemoglobin Levels After Transfusion | 174 ug/mL |
Secondary
Haptoglobin Levels 12 Hours After Transfusion
Haptoglobin levels after transfusion
Time frame: 12 hours after transfusion
Population: Blood samples to measure haptoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Refrigerated RBCs 0-14 Days Old | Haptoglobin Levels 12 Hours After Transfusion | 897 ng/mL |
| Refrigerated RBCs 15-42 Days Old | Haptoglobin Levels 12 Hours After Transfusion | 1470 ng/mL |
| Frozen RBCs | Haptoglobin Levels 12 Hours After Transfusion | 1350 ng/mL |
Secondary
Number of Participants With Acute Renal Failure
Number of participants who developed acute renal failure while hospitalized.
Time frame: from time of randomization through hospital discharged, assessed up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Refrigerated RBCs 0-14 Days Old | Number of Participants With Acute Renal Failure | 7 Participants |
| Refrigerated RBCs 15-42 Days Old | Number of Participants With Acute Renal Failure | 7 Participants |
| Frozen RBCs | Number of Participants With Acute Renal Failure | 10 Participants |