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

Leukemia Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anemia
• Anemia, Aplastic
• Aplastic Anemia
• Bone Marrow Failure
• Hematologic Diseases
• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm
• Leukemia
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Pancytopenia
• Preleukemia

• NCT number: NCT03086252
• Study type: Interventional
• Source: Emory University
• Status: Withdrawn
• Phase: N/A
• Start date: July 24, 2017
• Completion date: May 31, 2018