Clinical trial NCT02566577: Physiologic Effects of RBC Transfusion
Official title: Physiologic Effects of RBC Storage in Chronic Transfusion Recipients: Vasoreactivity, Exercise Capacity, and Oxygen Consumption
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Red Blood Cell Transfusion
Keywords: Chronic anemia
Cardiopulmonary testing
Transfusion-dependent anemia
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-10-02
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Flow-mediated Vasodilation (FMD)
timeFrame: Baseline (prior to transfusion), Day 1 (first post-transfusion day)
measure: Change in Reactive Hyperemic Index (RHI)
timeFrame: Baseline (prior to transfusion), Day 1 (first post-transfusion day)
Secondary outcomes:
measure: Maximal Oxygen Uptake (VO2Max)
timeFrame: Day 1 (first post-transfusion day)
measure: Respiratory Exchange Ratio (RER):
timeFrame: Day 1 (first post-transfusion day)
measure: O2 Pulse
timeFrame: Day 1 (first post-transfusion day)
measure: Peak VO2 Lean
timeFrame: Day 1 (first post-transfusion day)
measure: Change in Oxidative Stress Markers
timeFrame: Baseline (prior to transfusion), Day 1 (first post-transfusion day)
measure: Change in Levels of Nitric Oxide Metabolites
timeFrame: Baseline (prior to transfusion), Day 1 (first post-transfusion day)
measure: Change in High-sensitivity C-reactive Protein (hsCRP)hsCRP
timeFrame: Baseline (prior to transfusion), Day 1 (first post-transfusion day)
measure: Change in Levels of IL-6
timeFrame: Baseline (prior to transfusion), Day 1 (first post-transfusion day)
measure: Change in Levels of IL-2
timeFrame: Baseline (prior to transfusion), Day 1 (first post-transfusion day)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Arshed Quyyumi, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References: