Effects of Transfusion of Older Stored Red Cells

August 11, 2016 updated by: Steven L. Spitalnik, Columbia University

Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transfusion of Fresh 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.
Procedure: Transfusion
A routine medical procedure to transfuse packed red blood cells.
Other Names:
  • RBC transfusion
Biological: Blood

Processing of RBC for transfusion include the following:

  • Fresh
  • Stored
  • Washed
  • Frozen (Cryopreserved)
Other Names:
  • RBC product
  • Reb Blood Cells
Procedure: Chelation therapy
(non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.
Experimental: Transfusion of Stored 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.
Procedure: Transfusion
A routine medical procedure to transfuse packed red blood cells.
Other Names:
  • RBC transfusion
Biological: Blood

Processing of RBC for transfusion include the following:

  • Fresh
  • Stored
  • Washed
  • Frozen (Cryopreserved)
Other Names:
  • RBC product
  • Reb Blood Cells
Procedure: Chelation therapy
(non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.
Active Comparator: Transfusion of Cryopreserved Blood
The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy.
Procedure: Transfusion
A routine medical procedure to transfuse packed red blood cells.
Other Names:
  • RBC transfusion
Biological: Blood

Processing of RBC for transfusion include the following:

  • Fresh
  • Stored
  • Washed
  • Frozen (Cryopreserved)
Other Names:
  • RBC product
  • Reb Blood Cells
Active Comparator: Transfusion of Washed 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.
Procedure: Transfusion
A routine medical procedure to transfuse packed red blood cells.
Other Names:
  • RBC transfusion
Biological: Blood

Processing of RBC for transfusion include the following:

  • Fresh
  • Stored
  • Washed
  • Frozen (Cryopreserved)
Other Names:
  • RBC product
  • Reb Blood Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Non-transferrin-bound Iron Level
Time Frame: 2 hours after transfusion
2 hours after transfusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Steven Spitalnik, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 14, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (Estimate)

February 17, 2012

Study Record Updates

Last Update Posted (Estimate)

October 5, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAI1111
  • R01HL098014 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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