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The purpose of this pilot research study is to evaluate the effectiveness of blood and platelet transfusions in improving symptoms and quality of life of patients enrolled in hospice.
This is a non-randomized pilot study to investigate the feasibility of symptom-based blood transfusion in patients with hematologic malignancies enrolling in hospice care.
The study will be a case series involving OU Medical Center (OUMC). Patients will be identified at the University of Oklahoma/Stephenson Cancer Center (OU-SCC) where investigators performing the study will consent and monitor patients. Integris Home Hospice agency will provide hospice patients with blood transfusions in those willing to participate, and the Oklahoma Blood Institute (OBI) will provide the hospice patients with palliative transfusions at home at no cost to the patient, including blood products, transfusion testing, infusions and the nursing staff.
This will be a pilot project including 20 consented patients with hematologic malignancies enrolling in hospice through Integris Home Hospice. The transfusions received will be determined by the hospice team, and will not be based on objective symptom based guidelines. Patients will have the option to either be enrolled on this clinical trial, where they may receive home based blood or platelet transfusions, or be enrolled in any other hospice of their choosing, including the other hospice that will provide home based transfusions. Information will be collected regarding symptoms, Hospice QOL scores and transfusion use, reactions, and time in hospice. Data will be collected until death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranfusions and blood collection | Experimental | Patients enrolled will receive one unit each of blood and/or platelet transfusions once a week based on trigger symptoms of anemia and/or thrombocytopenia, along with blood sample collections. Data on patient demographics, disease, and length of hospice stay will also be collected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood and/or platelet transfusion | Procedure | The transfused patients will receive one unit each of blood and/or platelet transfusions once a week based on CTCAE symptom grade 2 or greater of anemia and/or thrombocytopenia. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with improved quality of life after receiving transfusions. | Improved quality of life (QOL) and palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires. | 6 months |
| Proportion of subjects with improved palliative efficacy after receiving transfusions. | Palliative efficacy will be evaluated by improvement of the presenting symptoms and quality of life based on CTCAE and QOL questionnaires. | 6 months |
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Patients >= 18 years irrespective of their race, sex and/or other medical history.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Holter, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73117 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D017713 | Platelet Transfusion |
| D001772 | Blood Cell Count |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Complete blood count (CBC) collection | Procedure | CBC will be collected from patients weekly while on this protocol. |
|
| D002452 |
| Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006403 | Hematologic Tests |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |