Red Cell Transfusion Goals in Patients With Acute Leukemias

Brief Title

Red Cell Transfusion Goals in Patients With Acute Leukemias

Official Title

Prospective Randomized Clinical Feasibility Study of Red Cell Transfusion Goals in Patients With Acute Leukemias

Brief Summary

      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.
    

Detailed Description

      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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Tolerance of low transfusion threshold as assessed by the percentage of participants who crossed over from the low arm to the high arm.

Secondary Outcome

 Safety of low vs. high transfusion threshold as assessed by total difference in number of transfusions given per participant

Condition

Acute Lymphoblastic Leukemia

Intervention

Red blood cell transfusion

Study Arms / Comparison Groups

 Low transfusion threshold

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Biological

Estimated Enrollment

90

Start Date

April 2014

Completion Date

September 2015

Primary Completion Date

September 2015

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Amy DeZern, MD, MHS, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02086773

Organization ID

J13126

Secondary IDs

NA_00089706

Responsible Party

Sponsor

Study Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Sponsor

Amy DeZern, MD, MHS, Principal Investigator, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Verification Date

January 2019