Red Cell Transfusion Goals in Patients With Acute Leukemias

Transfusion of red blood cells (RBCs) is vitally important for the care of patients
undergoing myelosuppressive therapy for acute leukemia. The therapeutic approach to this
disease involves the use of high doses of chemotherapy to treat the blood cancers and bone
marrow disorders; but it damages the marrow and blood system. Malignant and healthy stem
cells are affected by the chemotherapy, and even when the malignant cells are killed, it can
take weeks for the healthy cells to reconstitute the marrow. At diagnosis and before bone
marrow recovery post treatment, RBCs are needed to support the patient. Current practices at
major comprehensive cancer centers all utilize liberal hemoglobin transfusions triggers of
8-9 g/dL or higher. Higher hemoglobin levels in these high risk patients may have benefits
such as better energy and organ function. However, research in a variety of clinical
settings, suggests that a higher hemoglobin transfusion threshold is associated with the same
or even higher mortality rates compared to lower hemoglobin thresholds (7-8 g/dL). These
other settings include prospective randomized trials in high-risk orthopedic surgery
patients, critically ill adult and pediatric ICU patients, acute GI bleed patients, and
patients undergoing cardiac surgery. One clinical scenario where the ideal transfusion
threshold is unknown is in patients receiving chemotherapy for hematologic malignancies.
Transfusion requirements and triggers have not been systematically studied in acute leukemia
or other cancers. Acute leukemia carries a high mortality; any unnecessary increase in
morbidity or mortality is not acceptable. Without a clear benefit of higher transfusion
thresholds, the added risks and costs of transfusion may be substantial and unnecessary. The
investigators plan to study this issue in this pilot and feasibility study by randomly
assigning patients treated for acute leukemia to be transfused with RBCs at either a higher
or lower hemoglobin concentration trigger point. In this way, the investigators will be able
to accurately determine if there is benefit or harms to having a lower or higher red cell
count during the induction treatment and recovery period for patients with acute leukemias.
This study will also collect information evaluating the advantages and disadvantages of the
two transfusion thresholds and the feasibility of expanding the study to a large randomized
trial.This safety data will serve as a platform for a larger mortality study in leukemia and
possibly additional studies in solid tumors.

Inclusion Criteria:

- Acute leukemia patients (AML, ALL, APL, treatment-related myeloid neoplasm, high grade
MDS)

- Admitted with plans for inpatient myelosuppressive chemotherapy (with standard of care
or protocol regimens)

Exclusion Criteria:

- Age less than 18 years

- Acute coronary syndrome as defined by active chest pain, dynamic ECG changes, troponin
greater than 2.5

- Active blood loss

- Receiving erythropoietin stimulating agents prior to admission

- Chronic Renal Failure in Renal Replacement Therapy

- Documented wish against transfusion for personal or religious beliefs