Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Transfusion of Older Stored Red Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01534676
Recruitment Status : Terminated (Difficulty recruiting donors and recipients, looking for alternative sites)
First Posted : February 17, 2012
Results First Posted : October 5, 2016
Last Update Posted : October 5, 2016
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steven L. Spitalnik, Columbia University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Thalassemia Procedure: Transfusion Biological: Blood Procedure: Chelation therapy Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation
Study Start Date : February 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Non-transferrin-bound Iron Level [ Time Frame: 2 hours after transfusion ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534676


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Steven Spitalnik, MD Columbia University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Steven L. Spitalnik, Professor of Pathology and Cell Biology, Columbia University
ClinicalTrials.gov Identifier: NCT01534676    
Other Study ID Numbers: AAAI1111
R01HL098014 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2012    Key Record Dates
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Steven L. Spitalnik, Columbia University:
iron
transfusion
red blood cells
 sickle cell disease
thalassemia
blood donors
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn