Iron, Abnormal Blood Level, Other Abnormal Blood Chemistry
Conditions
Keywords
red blood cells, transfusion, storage, sickle cell disease, β-thalassemia, hemoglobin-associated iron
Brief summary
Packed red blood cell units destined for transfusion can be stored for up to 42 days prior to transfusion based on Food and Drug Administration (FDA) guidelines. Recent studies suggest that certain patients transfused with blood stored for longer duration have poorer outcomes than patients transfused fresher blood. The investigators' hypothesis is that the delivery of an immediate and substantial load of hemoglobin-associated iron from a stored unit of blood leads to changes that explain the differences in outcome between patients transfused old versus fresh blood. The investigators propose to test this hypothesis in humans by transfusing an individual's own blood, both fresh and after storage, and comparing levels of various outcome measures.
Detailed description
Participants in this study will be asked to participate in a standard blood donation. The blood will be processed per standards at the investigators regional blood center (New York Blood Center) and then split into two equal units and shipped to Columbia University Medical Center for storage and transfusion. One unit will be transfused back into the same individual fresh (i.e. between 3-7 days after donation). The other unit will be transfused 42 days after donation. Blood samples will be drawn before, during, and after transfusion to measure levels of various analytes.
Interventions
PROCEDUREFresh transfusion
1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
PROCEDUREOld transfusion
1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy * male body weight \>130 lbs, female body weight \> 155 lbs * male height \>5'1, female height \>5'5 * hemoglobin \>13.3 g/dL
Exclusion criteria
* ineligible for donation based on the New York Blood Center autologous blood donor questionnaire * systolic blood pressure \>180 or \<90 mm Hg * diastolic blood pressure \>100 or \<50 mm Hg * heart rate \<50 or \>100 * temperature \>99.5 F prior to donation * temperature \>100.4 F or subjective feeling of illness prior to transfusion * positive results on standard blood donor infectious disease testing * pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of Non-transferrin-bound Iron | four hours after transfusion | Comparison of increase in non-transferrin-bound iron for each participant between his or her fresh and old blood transfusion four hours after transfusion. |
Countries
United States
Participant flow
Recruitment details
The recruitment of volunteers began in December 2008 and ended in October 2010. All the volunteers were recruited at Columbia University.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Transfusion |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
Primary
Measure of Non-transferrin-bound Iron
Comparison of increase in non-transferrin-bound iron for each participant between his or her fresh and old blood transfusion four hours after transfusion.
Time frame: four hours after transfusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fresh Transfusion | Measure of Non-transferrin-bound Iron | 0.16 μM | Standard Deviation 0.99 |
| Old Transfusion | Measure of Non-transferrin-bound Iron | 3.17 μM | Standard Deviation 3.26 |