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Effects of Transfusion of Older Stored Red Cells

This study has been terminated.
(Difficulty recruiting donors and recipients, looking for alternative sites)
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven L. Spitalnik, Columbia University
ClinicalTrials.gov Identifier:
NCT01534676
First received: February 14, 2012
Last updated: August 11, 2016
Last verified: August 2016
  Purpose

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.


Condition Intervention
Sickle Cell Disease
Thalassemia
Procedure: Transfusion
Biological: Blood
Procedure: Chelation therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Non-transferrin-bound Iron Level [ Time Frame: 2 hours after transfusion ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: February 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: RBC transfusion
Biological: Blood

Processing of RBC for transfusion include the following:

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

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.
  Eligibility

Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534676

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Steven Spitalnik, MD Columbia University
  More Information

Responsible Party: Steven L. Spitalnik, Professor of Pathology and Cell Biology, Columbia University
ClinicalTrials.gov Identifier: NCT01534676     History of Changes
Other Study ID Numbers: AAAI1111  R01HL098014 
Study First Received: February 14, 2012
Results First Received: August 11, 2016
Last Updated: August 11, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Columbia University:
iron
transfusion
red blood cells
sickle cell disease
thalassemia
blood donors

Additional relevant MeSH terms:
Anemia, Sickle Cell
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on December 09, 2016