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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL098014 | U.S. NIH Grant/Contract | View source |
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Difficulty recruiting donors and recipients, looking for alternative sites
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The purpose of this study is to determine the effects of transfusion of fresh and stored blood on patients.
The investigators hope to test:
These findings may explain the immunomodulatory effects of older stored blood in patients and will help us develop safer transfusion products for patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transfusion of Fresh blood | Active Comparator | 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. |
|
| Transfusion of Stored blood | Experimental | 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. |
|
| Transfusion of Cryopreserved Blood | Active Comparator | The recipient will receive one or two units of cryopreserved (fresh/old) blood, as per their chronic transfusion schedule - off chelation therapy. |
|
| Transfusion of Washed Blood | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfusion | Procedure | A routine medical procedure to transfuse packed red blood cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-transferrin-bound Iron Level | 2 hours after transfusion |
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Inclusion Criteria (Recipient):
Exclusion Criteria (Recipient):
Inclusion Criteria (Donor):
Exclusion Criteria (Donor):
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| Name | Affiliation | Role |
|---|---|---|
| Steven Spitalnik, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Recipients | 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. |
| FG001 | Donors | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recipients | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Non-transferrin-bound Iron Level | Enrolled participants (recipients) were never randomized or received transfusion on study because study closed due to poor enrollment. No data was collected or analyzed. | Posted | 2 hours after transfusion |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Recipients | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eldad Hod, MD | Columbia University Medical Center | 212-342-5648 | eh2217@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001800 | Blood Specimen Collection |
| D015913 | Chelation Therapy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
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|
| Blood | Biological | Processing of RBC for transfusion include the following:
|
|
|
| Chelation therapy | Procedure | (non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body. |
|
| Donors |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Donors | 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. | 0 | 1 | 0 | 1 |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |