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| Name | Class |
|---|---|
| United States Air Force | FED |
| Armed Services Blood Program | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refrigerated RBCs 0-14 days old | Active Comparator | Standard, refrigerated RBC units stored up to 14 days |
|
| Refrigerated RBCs 15-42 days old | Active Comparator | Standard, refrigerated RBC units stored 15-42 days |
|
| Frozen RBCs | Experimental | RBC units stored frozen at -80 degrees Celsius, then thawed and deglycerolized using the ACP 215. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RBC units | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tissue Oxygenation | Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion. | Percentage of baseline (3 hours post transfusion compared to baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 2,3 DPG Levels After Transfusion | 2,3 DPG levels 12 hours after transfusion | 12 hours post transfusion |
| Free Hemoglobin Levels After Transfusion | Free hemoglobin levels 12 hours after transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Schreiber, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | United States | |||
| Oregon Health & Science University |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Refrigerated RBCs 15-42 Days Old |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tissue Oxygenation | Assessment of tissue oxygenation by NIRS in subjects up to 3 hours after PRBC transfusion. | 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. | Posted | Mean | Standard Deviation | percentage of baseline | Percentage of baseline (3 hours post transfusion compared to baseline) |
|
Adverse event data was collected during the patient's hospital admission, up to 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | General disorders | Systematic Assessment | Pulmonary Embolism |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment | All infections |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martin A. Schreiber | Oregon Health & Science University | 503-494-8324 | schreibm@ohsu.edu |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D000740 | Anemia |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| 12 hours after transfusion |
| Haptoglobin Levels 12 Hours After Transfusion | Haptoglobin levels after transfusion | 12 hours after transfusion |
| Clinical Outcomes - Hospital Days | Clinical outcomes - Number of days admitted to the hospital within a 6 month window. | from time of randomization through hospital discharged, assessed up to 6 months |
| Clinical Outcomes - ICU Days | Number of days admitted to the ICU during hospital admission | from time of randomization through hospital discharged, assessed up to 6 months |
| Clinical Outcomes - Ventilator Days | from time of randomization through hospital discharged, assessed up to 6 months |
| Number of Participants With Acute Renal Failure | Number of participants who developed acute renal failure while hospitalized. | from time of randomization through hospital discharged, assessed up to 6 months |
| Clinical Outcomes - Acute Respiratory Distress Syndrome | Number of subjects who developed acute respiratory distress syndrome while hospitalized. | from time of randomization through hospital discharged, assessed up to 6 months |
| Clinical Outcomes - Infections | Number of subjects who developed infections while hospitalized. | from time of randomization through hospital discharged, assessed up to 6 months |
| Portland |
| Oregon |
| 97239 |
| United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Injury Severity Score | Median | Inter-Quartile Range | units on a scale (1 best to 75 worst) |
|
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. |
| OG002 | 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. |
|
|
| Secondary | 2,3 DPG Levels After Transfusion | 2,3 DPG levels 12 hours after transfusion | Blood samples to measure 2,3 DPG levels could not be collected from all subjects 12 hours after transfusion or results were not measurable. | Posted | Median | Inter-Quartile Range | g/L | 12 hours post transfusion |
|
|
|
| Secondary | Free Hemoglobin Levels After Transfusion | Free hemoglobin levels 12 hours after transfusion | Blood samples to measure free hemoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable. | Posted | Median | Inter-Quartile Range | ug/mL | 12 hours after transfusion |
|
|
|
| Secondary | Haptoglobin Levels 12 Hours After Transfusion | Haptoglobin levels after transfusion | Blood samples to measure haptoglobin could not be collected from all subjects 12 hours after transfusion or the results were not measurable. | Posted | Median | Inter-Quartile Range | ng/mL | 12 hours after transfusion |
|
|
|
| Secondary | Clinical Outcomes - Hospital Days | Clinical outcomes - Number of days admitted to the hospital within a 6 month window. | Posted | Median | Inter-Quartile Range | days | from time of randomization through hospital discharged, assessed up to 6 months |
|
|
|
| Secondary | Clinical Outcomes - ICU Days | Number of days admitted to the ICU during hospital admission | Posted | Median | Inter-Quartile Range | days | from time of randomization through hospital discharged, assessed up to 6 months |
|
|
|
| Secondary | Clinical Outcomes - Ventilator Days | Posted | Median | Inter-Quartile Range | days | from time of randomization through hospital discharged, assessed up to 6 months |
|
|
|
| Secondary | Number of Participants With Acute Renal Failure | Number of participants who developed acute renal failure while hospitalized. | Posted | Count of Participants | Participants | from time of randomization through hospital discharged, assessed up to 6 months |
|
|
|
| Secondary | Clinical Outcomes - Acute Respiratory Distress Syndrome | Number of subjects who developed acute respiratory distress syndrome while hospitalized. | Posted | Count of Participants | Participants | from time of randomization through hospital discharged, assessed up to 6 months |
|
|
|
| Secondary | Clinical Outcomes - Infections | Number of subjects who developed infections while hospitalized. | Posted | Count of Participants | Participants | from time of randomization through hospital discharged, assessed up to 6 months |
|
|
|
| 3 |
| 82 |
| 5 |
| 82 |
| 24 |
| 82 |
| EG001 | 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. | 3 | 86 | 6 | 86 | 22 | 85 |
| EG002 | 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. | 3 | 86 | 8 | 86 | 24 | 86 |
| Sepsis | General disorders | Systematic Assessment | Sepsis |
|
| Deep Vein Thrombosis | General disorders | Systematic Assessment | Deep Vein Thrombosis |
|
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| Male |
|