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Effects of Transfusion of Older Stored Red Cells

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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

Tracking Information
First Submitted Date  ICMJE February 14, 2012
First Posted Date  ICMJE February 17, 2012
Results First Submitted Date  ICMJE August 11, 2016
Results First Posted Date  ICMJE October 5, 2016
Last Update Posted Date October 5, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
Non-transferrin-bound Iron Level [ Time Frame: 2 hours after transfusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2012)
Non-transferrin-bound iron [ Time Frame: 2 hours after transfusion ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2012)
  • transferrin saturation [ Time Frame: 2 hours following transfusion ]
  • pro-inflammatory cytokines [ Time Frame: 2 hours after transfusion ]
    Interleukin (IL)-6 and monocyte chemoattractant protein (MCP)-1 will be measured.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Transfusion of Older Stored Red Cells
Official Title  ICMJE Harmful Effects of Transfusion of Older Stored Red Cells: Iron and Inflammation
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Disease
  • Thalassemia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Transfusion
    • Biological: Blood
    • Procedure: Chelation therapy
  • 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.
    Interventions:
    • Procedure: Transfusion
    • Biological: Blood
    • Procedure: Chelation therapy
  • 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.
    Interventions:
    • Procedure: Transfusion
    • Biological: Blood
  • 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.
    Interventions:
    • Procedure: Transfusion
    • Biological: Blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 15, 2015)
3
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2012)
60
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01534676
Other Study ID Numbers  ICMJE AAAI1111
R01HL098014 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Steven L. Spitalnik, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Steven Spitalnik, MD Columbia University
PRS Account Columbia University
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP