Leukemia, Lymphoblastic, Acute, Leukemia, Myeloid, Acute
Conditions
Keywords
Leukemia, Transfusion
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Rochester
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 50 Years
Healthy volunteers
No
Inclusion criteria
* previously untreated patients with a diagnosis of acute leukemia between the ages of 0 and 50 (AML) and 18 and 50 (ALL)
Exclusion criteria
* all other patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survial Rate at 30 Days | 30 days | The percentage of patients who were alive at 30 days after transfusion. |
| Survial Rate at 60 Days | 60 days | The percentage of patients who were alive at 60 days after transfusion. |
| Survial Rate at 100 Days | 100 days | The percentage of patients who were alive at 100 days after transfusion. |
| Survial Rate at 5 Years | 5 years | The percentage of patients who were alive at 5 years after transfusion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Washed Washed red blood cell transfusions given to all patients with acute myeloid leukemia. | 69 |
| Unwashed Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient. | 31 |
| Total | 100 |
Baseline characteristics
| Characteristic | Washed | Unwashed | Total |
|---|---|---|---|
| Age, Continuous | 40 years | 30 years | 35 years |
| Region of Enrollment United States | 69 participants | 31 participants | 100 participants |
| Sex: Female, Male Female | 46 Participants | 18 Participants | 64 Participants |
| Sex: Female, Male Male | 23 Participants | 13 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Survial Rate at 100 Days
The percentage of patients who were alive at 100 days after transfusion.
Time frame: 100 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Washed | Survial Rate at 100 Days | 96 percentage of participants |
| Unwashed | Survial Rate at 100 Days | 87 percentage of participants |
Primary
Survial Rate at 30 Days
The percentage of patients who were alive at 30 days after transfusion.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Washed | Survial Rate at 30 Days | 100 percentage of participants |
| Unwashed | Survial Rate at 30 Days | 97 percentage of participants |
Primary
Survial Rate at 5 Years
The percentage of patients who were alive at 5 years after transfusion.
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Washed | Survial Rate at 5 Years | 55 percentage of participants |
| Unwashed | Survial Rate at 5 Years | 39 percentage of participants |
Primary
Survial Rate at 60 Days
The percentage of patients who were alive at 60 days after transfusion.
Time frame: 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Washed | Survial Rate at 60 Days | 97 percentage of participants |
| Unwashed | Survial Rate at 60 Days | 94 percentage of participants |