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| Name | Class |
|---|---|
| Duke University | OTHER |
| Vitalant Research Institute | OTHER |
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This study is designed to determine if point-of-care washing of allogeneic Leukocyte-Reduced Red Blood Cells reduces pulmonary complications when compared to standard-of-care Leukocyte-Reduced Red Blood Cells in a cardiac surgical population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care red blood cell transfusion | Active Comparator | Red blood cells that are administered in the normal fashion. |
|
| Point-of-Care washed red blood cell transfusion | Experimental | Red blood cells that are washed at the point-of-care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point-of-care washed red blood cell transfusion. | Biological |
| ||
| Standard of care red blood cell transfusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload. | This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury. | 18 hours after the initiation of the first red blood cell transfusion. |
| Number of "Off-protocol" Transfusions | The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion. | Day of surgery. Approximately 1 day. |
| Change in Recipient Hemoglobin | Change in Hemoglobin from pre-transfusion to post-transfusion | Pre to 6 hours post transfusion |
| Change in Recipient Cell Free Hemoglobin(CFH) | Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion | Pre transfusion until study day 5 or hospital discharge, approximately 5 days |
| Change in Haptoglobin | Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion | Pre transfusion to study day 5 or hospital discharge, approximately 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Mechanical Ventilation | Number of hours subject received mechanical ventilation. | Up to hospital day 28, or discharge, whichever comes first |
| Duration of Oxygen Supplementation | Number of hours subjects received supplemental oxygen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daryl Kor, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28821525 | Derived | Warner MA, Welsby IJ, Norris PJ, Silliman CC, Armour S, Wittwer ED, Santrach PJ, Meade LA, Liedl LM, Nieuwenkamp CM, Douthit B, van Buskirk CM, Schulte PJ, Carter RE, Kor DJ. Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery. BMJ Open. 2017 Aug 18;7(8):e016398. doi: 10.1136/bmjopen-2017-016398. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Red Blood Cell Transfusion | Red blood cells that are administered as standard of care. Standard of care red blood cell transfusion. |
| FG001 | Point-of-Care Washed Red Blood Cell Transfusion | Red blood cells that are washed at the point-of-care. Point-of-care washed red blood cell transfusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Red Blood Cell Transfusion | Red blood cells that are administered in the normal fashion. Standard of care red blood cell transfusion. |
| BG001 | Point-of-Care Washed Red Blood Cell Transfusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Biomarkers Associated With Transfusion-Related Acute Lung Injury and Transfusion Associated Circulatory Overload. | This panel of biomarkers measures inflammation, altered coagulation, and endothelial activation all of which play key roles in the pathogenesis of lung injury. | Patients undergoing cardiac surgery who were predicted to be at high risk for requiring red blood cell transfusion. | Posted | Median | Inter-Quartile Range | units on a scale (pg/ml) | 18 hours after the initiation of the first red blood cell transfusion. |
|
From randomization to hospital discharge, death, or day 28 (whichever occurs first).
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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 | Standard of Care Red Blood Cell Transfusion | Red blood cells transfusion that were administered in the standard of care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoxemia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daryl Kor | Mayo Clinic | 507-255-6051 | kor.daryl@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2019 | Feb 3, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065227 | Transfusion Reaction |
| D000073617 | Transfusion-Related Acute Lung Injury |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007154 | Immune System Diseases |
| D055371 | Acute Lung Injury |
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| Biological |
|
| Up to day 28, or hospital discharge, whichever comes first |
| Sequential Organ Failure Assessment (SOFA) Score | Worst SOFA score between Day 1 and Day 5. SOFA scores range from 0-24 with 0 meaning no organ dysfunction and 24 means severe dysfunction of all organ systems evaluated. Each of 6 organ systems are scored on a 0-4 scale with the cumulative score being the total SOFA score. | Through postoperative day 5. |
| Hospital Length of Stay | Number of days subject remained in the hospital following their surgical procedure. If the number of days the subject remained in the hospital exceeded 28, a value of 28 is assigned. | Up to day 28 |
| Post Transfusion Respiratory Complications. | Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO). | Up to day 28 |
| Durham |
| North Carolina |
| 27710 |
| United States |
Red blood cells that are washed at the point-of-care.
Point-of-care washed red blood cell transfusion.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Red blood cells transfusion that were washed at the point-of-care. |
|
|
| Primary | Number of "Off-protocol" Transfusions | The number of standard issued red blood cell units that were transfused to study participants in the washed red blood cell arm of the trial. Additionally, emergency red blood cell transfusions in the standard issued arm of the trial that were administered outside of the study protocol were also included to the definition of "off protocol" transfusion. | Posted | Number | transfusions | Day of surgery. Approximately 1 day. |
|
|
|
| Primary | Change in Recipient Hemoglobin | Change in Hemoglobin from pre-transfusion to post-transfusion | Posted | Median | Inter-Quartile Range | units on a scale (g/dl) | Pre to 6 hours post transfusion |
|
|
|
| Primary | Change in Recipient Cell Free Hemoglobin(CFH) | Change in CFH from pre-transfusion to worst (highest/maximum) post-transfusion | Posted | Median | Inter-Quartile Range | units on a scale (mg/dl) | Pre transfusion until study day 5 or hospital discharge, approximately 5 days |
|
|
|
| Primary | Change in Haptoglobin | Change in Haptoglobin from pre-transfusion to worst (minimum) post-transfusion | Posted | Median | Inter-Quartile Range | units on a scale (mg/dl) | Pre transfusion to study day 5 or hospital discharge, approximately 5 days |
|
|
|
| Secondary | Duration of Mechanical Ventilation | Number of hours subject received mechanical ventilation. | Posted | Median | Inter-Quartile Range | units on a scale (hours) | Up to hospital day 28, or discharge, whichever comes first |
|
|
|
| Secondary | Duration of Oxygen Supplementation | Number of hours subjects received supplemental oxygen. | Posted | Median | Inter-Quartile Range | units on a scale (hours) | Up to day 28, or hospital discharge, whichever comes first |
|
|
|
| Secondary | Sequential Organ Failure Assessment (SOFA) Score | Worst SOFA score between Day 1 and Day 5. SOFA scores range from 0-24 with 0 meaning no organ dysfunction and 24 means severe dysfunction of all organ systems evaluated. Each of 6 organ systems are scored on a 0-4 scale with the cumulative score being the total SOFA score. | Posted | Median | Inter-Quartile Range | units on a scale | Through postoperative day 5. |
|
|
|
| Secondary | Hospital Length of Stay | Number of days subject remained in the hospital following their surgical procedure. If the number of days the subject remained in the hospital exceeded 28, a value of 28 is assigned. | Posted | Median | Inter-Quartile Range | units on a scale (days) | Up to day 28 |
|
|
|
| Secondary | Post Transfusion Respiratory Complications. | Development of transfusion-related lung injury (TRALI) or transfusion-associated circulatory overload (TACO). | Posted | Number | participants | Up to day 28 |
|
|
|
| 2 |
| 85 |
| 0 |
| 85 |
| 0 |
| 85 |
| EG001 | Point-of-Care Washed Red Blood Cell Transfusion | Red blood cells transfusion that were washed at the point-of-care. | 3 | 86 | 7 | 86 | 0 | 86 |
| Profound Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
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| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |