NCT03086252

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Anemia
• Aplastic Anemia
• Bone Marrow Failure
• Hematopoietic and Lymphoid Cell Neoplasm
• Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
PROCEDURE	Red Blood Cell Transfusions (RBCT)	Undergo patient-driven RBCT

Timeline

• Start date: 2017-07-24
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2017-03-22
• Last updated: 2018-07-26

Locations

1 site across 1 country: United States