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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01059 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| Winship3145-16 | Other Identifier | Emory University/Winship Cancer Institute |
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Slow accrual
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This pilot study evaluates safety of administration of red blood cell transfusions requested by patients based on their symptoms instead of levels of hemoglobin for the treatment of chronic anemia in patients with blood disorders.
PRIMARY OBJECTIVE:
I. To assess feasibility and safety of red blood cell transfusions at the time subjects requested based on symptomatic anemia.
SECONDARY OBJECTIVES:
I. To define a patient-driven red blood cell transfusion (RBCT) threshold and to compare the median hemoglobin (hgb) at the time subjects request RBCT to the standard threshold of hgb < 8 g/dL.
II. To compare the number of red blood cell (RBC) units transfused and the frequency of transfusions at the time subjects request RBCT during the study period to the number of RBC units received and frequency using the standard threshold hemoglobin < 8 g/dL during a comparable period prior to enrollment.
III. To compare the quality of life (QoL) scores when subjects request RBCT to the scores obtained at the time hgb is 8 +/- 0.5 g/dL.
OUTLINE:
Patients undergo RBCT based on their perception and/or the presence of anemia symptoms for up to 6 months.
After completion of study treatment, patients are followed up for 30 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (patient-driven RBCT) | Experimental | Patients undergo red blood cell transfusions (RBCT) based on their perception and/or the presence of anemia symptoms for up to 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red Blood Cell Transfusions (RBCT) | Procedure | Undergo patient-driven RBCT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of laboratory and clinical adverse events (AEs) assessed by the Common Terminology Criteria for Adverse Events version 4.03. | Frequency, duration, and severity of AEs and severe adverse events will be determined. The proportion of subjects with serious side effects will be calculated with 95% confidence interval. Descriptive statistics will be used to characterize subjects enrolled on the trial: age, sex, race and diagnosis. | Up to 6 months of study participation |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of RBC units transfused | The frequency of RBC units transfused will be compared between study period and prior to enrollment for the same patient (e.g. each patient will serve his/her own control) by Wilcoxon's sign rank test. | Up to 6 months of study participation |
| Hemoglobin concentration at the time subject requests RBCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Antun, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D000741 | Anemia, Aplastic |
| D000080983 | Bone Marrow Failure Disorders |
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Hemoglobin concentration (Hgb) will be measured in g/dL. |
| Up to 6 months of study participation |
| Number of RBC units transfused | The number of RBC units transfused will be compared between study period and prior to enrollment for the same patient (e.g. each patient will serve his/her own control) by Wilcoxon's sign rank test. | Up to 6 months of study participation |
| QoL scores from the Functional Assessment of Cancer Therapy - Anemia/Fatigue (FACT-An) questionnaire at the time hemoglobin is 8 +/- 0.5 g/dL | Will be compared to QoL scores at the time subjects request RBCT by paired t-test and/or Wilcoxon sign rank test. | Up to 6 months of study participation |
| QoL scores from the Functional Assessment of Cancer Therapy - Anemia/Fatigue (FACT-An) questionnaire at the time subjects request RBCT | Will be compared to QoL scores at the time hgb is 8 +/- 0.5 g/dL by paired t-test and/or Wilcoxon sign rank test. | Up to 6 months of study participation |
| D009369 | Neoplasms |
| D009370 | Neoplasms by Histologic Type |