Effects of Transfusion of Older Stored Red Cells

Not Applicable

Terminated

• Conditions: Thalassemia; Sickle Cell Disease
• Interventions: Procedure: Transfusion; Biological: Blood; Procedure: Chelation therapy

• Registration Number: NCT01534676
• Lead Sponsor: Columbia University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-14
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-17
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-08
• Results First Submitted: 2016-08-11
• Results First Submitted QC: 2016-08-11
• Last Update Submitted: 2016-08-11
• Results First Posted: 2016-10-05
• Last Update Posted: 2016-10-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transfusion of Cryopreserved Blood	Blood	The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy.
Transfusion of Fresh blood	Chelation therapy	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.
Transfusion of Stored blood	Blood	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.
Transfusion of Cryopreserved Blood	Transfusion	The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy.
Transfusion of Washed Blood	Blood	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.
Transfusion of Fresh blood	Transfusion	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.
Transfusion of Stored blood	Transfusion	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.
Transfusion of Washed Blood	Transfusion	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.
Transfusion of Fresh blood	Blood	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.
Transfusion of Stored blood	Chelation therapy	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.

Primary Outcome Measures

Name	Time	Method
Non-transferrin-bound Iron Level	2 hours after transfusion

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States