Physiologic Effects of RBC Transfusion

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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

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Red Blood Cell Transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fresh RBC transfusion/Storage-aged RBC transfusion

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.

Group Type ACTIVE_COMPARATOR

Fresh red blood cell (RBC) transfusion

Intervention Type BIOLOGICAL

1 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.

Storage-aged red blood cell (RBC) transfusion

Intervention Type BIOLOGICAL

1 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.

Electronic infusion pump

Intervention Type DEVICE

A 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.

Storage-aged RBC transfusion/Fresh RBC transfusion

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).

Group Type ACTIVE_COMPARATOR

Fresh red blood cell (RBC) transfusion

Intervention Type BIOLOGICAL

1 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.

Storage-aged red blood cell (RBC) transfusion

Intervention Type BIOLOGICAL

1 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.

Electronic infusion pump

Intervention Type DEVICE

A 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.

Interventions

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Fresh red blood cell (RBC) transfusion

1 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.

Intervention Type BIOLOGICAL

Storage-aged red blood cell (RBC) transfusion

1 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.

Intervention Type BIOLOGICAL

Electronic infusion pump

A 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No