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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Sickle Cell Disease
Thalassemia
Interventions Procedure: Transfusion
Biological: Blood
Procedure: Chelation therapy
Enrollment 3
Recruitment Details This is a research study carried out at Columbia University Medical Center. Participants with a blood disorder and currently receive blood transfusions as treatment will be transfused fresh, stored, washed or frozen blood according to regular schedule for up to 3 years. Volunteer dedicated donors will also be asked to provide consent.
Pre-assignment Details Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment.
Arm/Group Title Recipients Donors
Hide Arm/Group Description Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion. Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
Period Title: Overall Study
Started 2 1
Completed 0 0
Not Completed 2 1
Reason Not Completed
Study closed due to poor enrollment             2             1
Arm/Group Title Recipients Donors Total
Hide Arm/Group Description Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion. Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor. Total of all reporting groups
Overall Number of Baseline Participants 2 1 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
<=18 years
2
 100.0%
0
   0.0%
2
  66.7%
Between 18 and 65 years
0
   0.0%
1
 100.0%
1
  33.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 3 participants
Female
0
   0.0%
1
 100.0%
1
  33.3%
Male
2
 100.0%
0
   0.0%
2
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 1 participants 3 participants
2 1 3
1.Primary Outcome
Title Non-transferrin-bound Iron Level
Hide Description [Not Specified]
Time Frame 2 hours after transfusion
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment. No data was collected or analyzed.
Arm/Group Title Recipients Donors
Hide Arm/Group Description:
Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Recipients Donors
Hide Arm/Group Description Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion. Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
All-Cause Mortality
Recipients Donors
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Recipients Donors
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Recipients Donors
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eldad Hod, MD
Organization: Columbia University Medical Center
Phone: 212-342-5648
EMail: eh2217@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Steven L. Spitalnik, Columbia University
ClinicalTrials.gov Identifier: NCT01534676    
Other Study ID Numbers: AAAI1111
R01HL098014 ( U.S. NIH Grant/Contract )
First Submitted: February 14, 2012
First Posted: February 17, 2012
Results First Submitted: August 11, 2016
Results First Posted: October 5, 2016
Last Update Posted: October 5, 2016