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| Name | Class |
|---|---|
| Marquette University | OTHER |
| Medical College of Wisconsin | OTHER |
| University of Wisconsin, Milwaukee | OTHER |
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A longitudinal, randomized, controlled, single-center Phase IV clinical trial will be performed to assess changes in bone mineral density (BMD) among voluntary apheresis blood donors. The primary outcome measure will be clinically significant decline in BMD at the lumbar spine assessed by dual-energy x-ray absorptiometry (DXA).
Apheresis blood donation maximizes an individual's donation by selecting specific blood components that are used to save patient lives. Dramatic increases in the number of apheresis procedures performed each year are apparent both domestically and internationally. Apheresis requires the use of citrate anticoagulation, a substance that confers its anticoagulant effect through chelation of cations, like calcium. A small number of cross-sectional studies have reported that intermittent exposure to citrate through apheresis is associated with significant declines in donor bone mineral density (BMD). In contrast, oral potassium citrate of much lower dose has been used to treat low bone density with well-documented efficacy. The impact of citrate exposure during apheresis, either positive or negative, is important given that BMD is a significant risk factor for low trauma fracture, a problem that affects more than 2M people in the U.S. annually. It is ultimately unknown what effect repeated apheresis has on skeletal health. To address this knowledge gap, we will perform a Phase IV clinical trial of apheresis blood donors using a cross-disciplinary, multi-institutional team. As apheresis blood donation continues to affect more people, the importance of understanding the effects of repeated exposure to citrate on donor skeletal health is essential in protecting this precious community resource.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | high frequency voluntary apheresis blood donation (i.e. 20 - 26 donations in one year period) |
|
| Control | No Intervention | no voluntary (or paid) apheresis blood donation (whole blood donation allowed during one year period) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high frequency voluntary apheresis blood donation | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dual Energy XRay Absorptiometry - Total Lumbar Spine | The primary outcome measure is a decline in total lumbar spine bone mineral density that exceeds the technologist's least significant change (LSC) as assessed by DXA. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Dual Energy XRay Absorptiometry - Femoral Neck | A secondary outcome measure includes a decline in left or right femoral neck bone mineral density that exceeds the technologist's least significant change (LSC) as assessed by DXA. | one year |
| Dual Energy XRay Absorptiometry - Total Hip |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paula E Papanek, PhD | Marquette University | Study Chair |
| Walter Bialkowski, MS | Versiti Blood Health | Study Director |
| Robert D Blank, MD, PhD | Medical College of Wisconsin | Principal Investigator |
| Jerome L Gottschall, MD | Versiti Blood Health | Principal Investigator |
| Cheng Zheng, PhD | University of Wisconsin, Milwaukee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BloodCenter of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
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A secondary outcome measure includes a decline in total hip bone mineral density that exceeds the technologist's least significant change (LSC) as assessed by DXA. |
| one year |
| Dual Energy XRay Absorptiometry - Total Body Composition | one year |