Fresh Versus Old Red Blood Cells for Transfusion

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven L. Spitalnik, Columbia University
ClinicalTrials.gov Identifier:
NCT01319552
First received: March 18, 2011
Last updated: May 15, 2015
Last verified: May 2015
Results First Received: March 10, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Iron, Abnormal Blood Level
Other Abnormal Blood Chemistry
Interventions: Procedure: Fresh transfusion
Procedure: Old transfusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment of volunteers began in December 2008 and ended in October 2010. All the volunteers were recruited at Columbia University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Transfusion Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions

Participant Flow:   Overall Study
    Transfusion  
STARTED     14  
COMPLETED     14  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Transfusion

Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions

1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions Old transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions


Baseline Measures
    Transfusion  
Number of Participants  
[units: participants]
  14  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     14  
>=65 years     0  
Gender  
[units: participants]
 
Female     4  
Male     10  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     12  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     1  
White     11  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     14  



  Outcome Measures

1.  Primary:   Measure of Non-transferrin-bound Iron   [ Time Frame: four hours after transfusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Steven Spitalnik
Organization: Columbia University
phone: 2123425648
e-mail: eldad.hod@gmail.com


Publications of Results:

Responsible Party: Steven L. Spitalnik, Columbia University
ClinicalTrials.gov Identifier: NCT01319552     History of Changes
Other Study ID Numbers: AAAD3737, R01HL098014
Study First Received: March 18, 2011
Results First Received: March 10, 2014
Last Updated: May 15, 2015
Health Authority: United States: Institutional Review Board