Clinical Trials Directory

Trials / Terminated

TerminatedNCT02566577

Physiologic Effects of RBC Transfusion

Physiologic Effects of RBC Storage in Chronic Transfusion Recipients: Vasoreactivity, Exercise Capacity, and Oxygen Consumption

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
15 (actual)
Sponsor
Emory University · Academic / Other
Sex
All
Age
21 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALFresh red blood cell (RBC) transfusion1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (\<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
BIOLOGICALStorage-aged red blood cell (RBC) transfusion1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (\>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
DEVICEElectronic infusion pumpA programmable, electronic infusion pump (Baxter, Inc) will be used for intravenous transfusion of units of packed red blood cells (RBC). The pump will be programmed to deliver 1 unit of packed RBC per hour.

Timeline

Start date
2013-07-01
Primary completion
2018-03-01
Completion
2018-03-01
First posted
2015-10-02
Last updated
2019-05-24
Results posted
2019-05-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02566577. Inclusion in this directory is not an endorsement.