Patient-Driven Transfusion Thresholds in Hematological Disorders: A Pilot Study

Emory University

Status: Withdrawn

Conditions: Anemia; Hematopoietic and Lymphoid Cell Neoplasm; Bone Marrow Failure; Myelodysplastic Syndrome; Leukemia; Aplastic Anemia

Treatments: Procedure: Red Blood Cell Transfusions (RBCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03086252

Winship3145-16 (Other Identifier)

IRB00090306

NCI-2016-01059 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with hematological malignancy or marrow failure syndrome such as but not limited to: aplastic anemia, myelodysplastic syndrome or leukemia
• Chronic transfusion-dependent anemia with exposure to at least 5 RBCT
• Interested in reducing transfusion exposure
• Willing to sign informed consent

Exclusion criteria

• Recent acute bleeding requiring intervention in less than 24 hours
• Hemoglobin levels < 6 g/dL
• Acute leukemia receiving induction chemotherapy
• Any patient with known ischemic heart disease, history of congestive heart failure, history of stroke, or cardiac arrhythmia for which the patient requires medication or a medical device
• Oxygen dependent
• Oxygen saturation below 92% on room air
• Receiving erythropoietin stimulating agent
• Thalassemia major or sickle cell disease requiring blood transfusion
• Undergoing major surgery
• Hemolytic anemia
• Coagulopathies including disseminated intravascular coagulation (DIC), receiving anticoagulant or antiplatelet agents
• Diagnosed with chronic obstructive pulmonary disease (COPD) oxygen dependent
• Pregnancy
• Participation in a therapeutic clinical trial

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive care (patient-driven RBCT)

Experimental group

Description:

Patients undergo red blood cell transfusions (RBCT) based on their perception and/or the presence of anemia symptoms for up to 6 months.

Treatment:

Procedure: Red Blood Cell Transfusions (RBCT)