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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
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 |

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:
Other Names:
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:
Other Names:
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:
Other Names:
|
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:
Other Names:
|
- Non-transferrin-bound Iron Level [ Time Frame: 2 hours after transfusion ]

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.
Ages Eligible for Study: | 1 Year to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 |
Principal Investigator: | Steven Spitalnik, MD | Columbia University |
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 |
iron transfusion red blood cells |
sickle cell disease thalassemia blood donors |
Anemia, Sickle Cell Thalassemia Anemia, Hemolytic, Congenital Anemia, Hemolytic |
Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |