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Adverse Effects of RBC Transfusions: A Unifying Hypothesis (INOBA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John D Roback, Emory University
ClinicalTrials.gov Identifier:
NCT00838331
First received: February 5, 2009
Last updated: March 4, 2015
Last verified: March 2015
Results First Received: February 13, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy Volunteers
Interventions: Biological: Fresh blood
Biological: Aged blood

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seven subjects withdrew prior to transfusion.

Reporting Groups
  Description
Fresh Blood, Then Aged Blood Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.

Participant Flow for 2 periods

Period 1:   Fresh Blood Transfusion
    Fresh Blood, Then Aged Blood
STARTED   17 
COMPLETED   17 
NOT COMPLETED   0 

Period 2:   Aged Blood Transfusion
    Fresh Blood, Then Aged Blood
STARTED   17 
COMPLETED   8 
NOT COMPLETED   9 
Withdrawal by Subject                9 



  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.
Only the 8 volunteers who completed both arms of this study are analyzed here.

Reporting Groups
  Description
All Subjects Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.

Baseline Measures
   All Subjects 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   8 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.6  (3.4) 
Gender 
[Units: Participants]
 
Female   3 
Male   5 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 
Caucasian   4 
African-American   1 
Asian-American   2 
"Other"   1 
[1] The volunteer population was composed of 4 Caucasians, 1 African-American, 2 Asian-Americans, and 1 participant whose race was categorized as "other".
Region of Enrollment 
[Units: Participants]
 
United States   8 


  Outcome Measures

1.  Primary:   The Effects of Storage-related RBC Changes on Acetylcholine-stimulated (NO-mediated) Forearm Blood Flow.   [ Time Frame: 5 years ]


  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
Primary limitation is that we are studying transfusion effects of fresh vs stored RBCs in healthy individuals, and not sick, anemic individuals as are often encountered in the hospital.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John Roback, MD PhD
Organization: Emory University
phone: 404-712-1774
e-mail: jroback@emory.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: John D Roback, Emory University
ClinicalTrials.gov Identifier: NCT00838331     History of Changes
Other Study ID Numbers: IRB00015316
Study First Received: February 5, 2009
Results First Received: February 13, 2015
Last Updated: March 4, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board