Effects of Transfusion of Older Stored Red Cells

Columbia University

Status: Terminated

Conditions: Thalassemia; Sickle Cell Disease

Treatments: Biological: Blood; Procedure: Transfusion; Procedure: Chelation therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01534676

AAAI1111

R01HL098014 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients.

The investigators hope to test:

• whether a similar effect (older stored blood is associated with worse outcomes) is seen in chronically transfused patients with hemoglobinopathies. This patient population will also allow the investigators to test whether iron- chelation therapy is beneficial in this setting.
• whether washing or cryopreserving the red blood cells has any effect on this outcome.

These findings may explain the immunomodulatory effects of older stored blood in patients and will help us develop safer transfusion products for patients.

Full description

Epidemiologic studies suggest that older stored blood is associated with worse outcomes in certain hospitalized patients. Storage of red cells is associated with a storage lesion and the survival of transfused red cells decreases with increasing storage time, thus older blood is associated with an increased acute delivery of hemoglobin-iron to the reticuloendothelial system. The investigators have preliminary data in healthy human volunteers suggesting that delivery of a significant iron load to the reticuloendothelial system from aged red cells leads to the elaboration of a potentially toxic form of iron known as non-transferrin-bound iron.

Enrollment: 3 patients

Sex: All

Ages: 1 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Recipient):

• specific, well-characterized hemoglobinopathy
• chronic simple transfusion therapy (transfusion episodes < 6 weeks apart in frequency)
• chronic iron chelation therapy
• not pregnant by self-report and not planning pregnancy
• age > 1 year old

Exclusion Criteria (Recipient):

• clinically unstable
• treatment for mental illness
• imprisonment
• institutionalization

Inclusion Criteria (Donor):

• 21-65 years of age
• male weight > 130 lbs, female weight > 150 lbs
• male height > 5'1", female height > 5'5"
• hemoglobin > 15.0 g/dL
• reasonably certain of intention to stay in New York City metropolitan area for study duration
• previously tolerated red blood cell donation

Exclusion Criteria (Donor):

• ineligible for donation based on New York Blood Center blood donor screening questionnaire
• systolic blood pressure < 90 or > 180 mm Hg, diastolic blood pressure < 50 or > 100 mm Hg
• heart rate < 50 or > 100
• temperature > 99.5 F prior to donation
• positive by standard infectious disease testing performed on blood donors

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 4 patient groups

Transfusion of Fresh blood

Active Comparator group

Description:

The recipient will receive one or two units of fresh blood \<14 days old, as per their chronic transfusion schedule - on or off chelation therapy.

Treatment:

Biological: Blood

Procedure: Transfusion

Procedure: Chelation therapy

Transfusion of Stored blood

Experimental group

Description:

The recipient will receive one or two units of old blood \>28 days old, as per their chronic transfusion schedule - on or off chelation therapy.

Treatment:

Biological: Blood

Procedure: Transfusion

Procedure: Chelation therapy

Transfusion of Cryopreserved Blood

Active Comparator group

Description:

The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy.

Treatment:

Biological: Blood

Procedure: Transfusion

Transfusion of Washed Blood

Active Comparator group

Description:

The recipient will receive one or two units of washed (fresh/old) stored blood \>28 days old, as per their chronic transfusion schedule - off chelation therapy.

Treatment:

Biological: Blood

Procedure: Transfusion