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Effects of Transfusion of Older Stored Red Cells

Primary Purpose

Sickle Cell Disease, Thalassemia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transfusion
Blood
Chelation therapy
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring iron, transfusion, red blood cells, sickle cell disease, thalassemia, blood donors

Eligibility Criteria

1 Year - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Active Comparator

Arm Label

Transfusion of Fresh blood

Transfusion of Stored blood

Transfusion of Cryopreserved Blood

Transfusion of Washed Blood

Arm 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.

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.

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

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.

Outcomes

Primary Outcome Measures

Non-transferrin-bound Iron Level

Secondary Outcome Measures

Full Information

First Posted
February 14, 2012
Last Updated
August 11, 2016
Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01534676
Brief Title
Effects of Transfusion of Older Stored Red Cells
Official Title
Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulty recruiting donors and recipients, looking for alternative sites
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Thalassemia
Keywords
iron, transfusion, red blood cells, sickle cell disease, thalassemia, blood donors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transfusion of Fresh blood
Arm Type
Active Comparator
Arm 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.
Arm Title
Transfusion of Stored blood
Arm Type
Experimental
Arm 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.
Arm Title
Transfusion of Cryopreserved Blood
Arm Type
Active Comparator
Arm Description
The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy.
Arm Title
Transfusion of Washed Blood
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Transfusion
Other Intervention Name(s)
RBC transfusion
Intervention Description
A routine medical procedure to transfuse packed red blood cells.
Intervention Type
Biological
Intervention Name(s)
Blood
Other Intervention Name(s)
RBC product, Reb Blood Cells
Intervention Description
Processing of RBC for transfusion include the following: Fresh Stored Washed Frozen (Cryopreserved)
Intervention Type
Procedure
Intervention Name(s)
Chelation therapy
Intervention Description
(non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.
Primary Outcome Measure Information:
Title
Non-transferrin-bound Iron Level
Time Frame
2 hours after transfusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Spitalnik, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Effects of Transfusion of Older Stored Red Cells

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