Red Cell Transfusion Goals in Patients With Acute Leukemias

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

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The purpose of this study to determine if a lower hemoglobin transfusion threshold, 7 g/dL, has a safety profile similar to that of the current standard transfusion threshold of 8 g/dL.

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Detailed Description

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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.

Conditions

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Acute Lymphoblastic Leukemia Acute Lymphocytic Leukemia (ALL) Acute Myelogenous Leukemia (AML) Acute Promyelocytic Leukemia (APL)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Low transfusion threshold

Patients receive red blood cell transfusions with a transfusion threshold of 7 g/dL hemoglobin (Hb). Transfusions will not be given on schedule but will be given whenever Hb dips below the threshold.

Group Type EXPERIMENTAL

Red blood cell transfusion

Intervention Type BIOLOGICAL

High transfusion threshold

Patients receive red blood cell transfusions with a transfusion threshold of 8 g/dL hemoglobin (Hb). Transfusions will not be given on schedule but will be given whenever Hb dips below the threshold.

Group Type ACTIVE_COMPARATOR

Red blood cell transfusion

Intervention Type BIOLOGICAL

Interventions

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Red blood cell transfusion

Intervention Type BIOLOGICAL

Other Intervention Names

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PRBC transfusion RBC transfusion

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No