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The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature.
The purpose of this study is to determine whether a novel standard of care protocol, washing red cell and platelet transfusions for younger patients with acute leukemia, has yielded improved clinical outcomes at Strong Memorial Hospital (Rochester, New York, USA). This standard of care was implemented based upon an earlier randomized trial (BMC Blood Disorders. 2004 Dec 10;4(1):6) The comparator will be historical controls from the medical literature. Key outcomes will be treatment related mortality (deaths at 30, 60 and 100 days) and three year survival.
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| Measure | Description | Time Frame |
|---|---|---|
| Survial Rate at 30 Days | The percentage of patients who were alive at 30 days after transfusion. | 30 days |
| Survial Rate at 60 Days | The percentage of patients who were alive at 60 days after transfusion. | 60 days |
| Survial Rate at 100 Days | The percentage of patients who were alive at 100 days after transfusion. | 100 days |
| Survial Rate at 5 Years | The percentage of patients who were alive at 5 years after transfusion. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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The study population is comprised of 98 men and women who were both diagnosed and treated for Acute Myeloid Leukemia or Acute Lymphoid Leukemia at Strong Memorial Hospital, a tertiary medical center located in Rochester, NY, USA. All of these patients received washed red cell and platelet transfusions as part of the hospital's standard protocol for patients with acute leukemia.
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| Name | Affiliation | Role |
|---|---|---|
| Neil Blumberg, M.D. | University of Rochester Medical Center, School of Medicine and Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strong Memorial Hospital (University of Rochester Medical Center) | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15588315 | Background | Blumberg N, Heal JM, Rowe JM. A randomized trial of washed red blood cell and platelet transfusions in adult acute leukemia [ISRCTN76536440]. BMC Blood Disord. 2004 Dec 10;4(1):6. doi: 10.1186/1471-2326-4-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Washed | Washed red blood cell transfusions given to all patients with acute myeloid leukemia. |
| FG001 | Unwashed | Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Washed | Washed red blood cell transfusions given to all patients with acute myeloid leukemia. |
| BG001 | Unwashed | Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient. |
| 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 | Survial Rate at 30 Days | The percentage of patients who were alive at 30 days after transfusion. | Posted | Number | percentage of participants | 30 days |
|
|
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Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed
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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 | Washed | Washed red blood cell transfusions given to all patients with acute myeloid leukemia. |
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This is a cohort study and thus has limits as to confounding and bias. However, it reproduces the results of a previous single center randomized trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil Blumberg MD | University of Rochester Medical Center | (585) 275-3189 | neil_blumberg@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Participants |
|
|
| Primary | Survial Rate at 60 Days | The percentage of patients who were alive at 60 days after transfusion. | Posted | Number | percentage of participants | 60 days |
|
|
|
| Primary | Survial Rate at 100 Days | The percentage of patients who were alive at 100 days after transfusion. | Posted | Number | percentage of participants | 100 days |
|
|
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| Primary | Survial Rate at 5 Years | The percentage of patients who were alive at 5 years after transfusion. | Posted | Number | percentage of participants | 5 years |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Unwashed | Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient. | 0 | 0 | 0 | 0 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |