Physiologic Effects of RBC Transfusion

Emory University

Status and phase: Terminated; Phase 4

Conditions: Red Blood Cell Transfusion

Treatments: Biological: Storage-aged red blood cell (RBC) transfusion; Device: Electronic infusion pump; Biological: Fresh red blood cell (RBC) transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02566577

IRB00064523

Details and patient eligibility

About

The purpose of this study is to determine how red blood cell transfusions, particularly the length of storage time of units of packed red blood cells, affects the cardiovascular function in patients receiving transfusions. This study will also determine the most ideal way of storing and processing blood, and assess how transfusion affects a person's ability to exercise and how their blood vessels relax and contract.

Full description

The purpose of this study is determine red blood cell transfusion, particularly the length of storage time of units of packed red blood cells, affects cardiovascular function in patients receiving transfusions. Transfusion of red blood cells is often used clinically in patients with low red blood cell counts in order to prevent disease progression and death. Recent studies suggest that the use of "aged" versus "fresh" red blood cells is associated with worse clinical outcomes, but there is no clear understanding on how this happens. The investigators want to determine the most ideal way of storing and processing blood, and learn how transfusion affects the ability to exercise in the study subjects and assess the relaxation and contraction of the blood vessels.

Enrollment: 15 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with any condition resulting in transfusion-dependent anemia

Exclusion criteria

• Age <21 or >80 years
• Pregnancy
• Acute infection in previous 4 weeks
• Active substance abuse within the past year
• Inability to give informed consent
• Inability to return for follow-up
• The presence of alloantibodies that would limit the blood bank's ability to obtain correctly aged red blood cell (RBC) units

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Fresh RBC transfusion/Storage-aged RBC transfusion

Active Comparator group

Description:

Subjects will receive a transfusion of packed red blood cell (RBC) units of fresh blood (\<10 days old) followed by a transfusion of packed RBC units of storage-aged (\>21 days old) blood.

Treatment:

Biological: Storage-aged red blood cell (RBC) transfusion

Biological: Fresh red blood cell (RBC) transfusion

Device: Electronic infusion pump

Storage-aged RBC transfusion/Fresh RBC transfusion

Active Comparator group

Description:

Subjects will receive a transfusion of packed red blood cell (RBC) units of storage-aged (\>21 days old) blood followed by a transfusion of packed RBC units of fresh blood (\<10 days old).

Treatment:

Biological: Storage-aged red blood cell (RBC) transfusion

Biological: Fresh red blood cell (RBC) transfusion

Device: Electronic infusion pump