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This study has successfully completed the feasibility phase. Forty-seven patients were enrolled at two sites. The results of the preliminary data indicated that the volumes of blood donated and the frequency of donation were well accepted by patients and safe. It also indicated that the formula for calculating volumes of blood to be removed to achieve the targeted reduction in Total Body Iron Stores (TBIS) was accurate and representative of the ferritin equivalence in storage iron found by others could be achieved.
Intervention: Ferritin reduction to 25 ng/ml by phlebotomy every 6 months vs placebo.
Minimum follow-up for each patient is 2.5 years.
Primary Hypothesis: Reduction of Total Body Iron Storage(TBIS) to a ferritin equivalent of approximately 25 ng/ml will alter mortality in a population of patients with advanced PVD.
Secondary Hypothesis: Reduction of TBIS to the same ferritin level will alter vascular disease morbidity in the same PVD patients population.
Primary Outcomes: Primary endpoint is mortality. Secondary endpoints include rates of non-fatal myocardial infarction and stroke, and the need for vascular intervention procedures.
Study Abstract: This study has successfully completed the feasibility phase. Forty-seven patients were enrolled at two sites. The results of the preliminary data indicated that the volumes of blood donated and the frequency of donation were well accepted by patients and safe. It also indicated that the formula for calculating volumes of blood to be removed to achieve the targeted reduction in Total Body Iron Stores (TBIS) was accurate and representative of the ferritin equivalence in storage iron found by others could be achieved.
This full study will last for six years. There will be 3.5 years of enrollment and a minimum of 2.5 years of follow-up for all study patients. It will involve a total of 1600 patients being recruited currently at 23 sites. Study patients will be seen every six months. Patients randomized to the ferritin reduction group will be monitored and have blood drawn to reach their targeted level of ferritin reduction of 25 ng/ml. The entry criteria will be the same as the feasibility study; however, the way patients will be stratified has changed. In the feasibility study, patients were stratified on the basis of their LDL/HDL ratios only. In this full study patients will be stratified on the basis of their entry LDL/HDL ratios as well as site, age, baseline ferritin level, smoking and diabetes status. Should the hypothesis of this study be confirmed, the results stand to have a considerable impact on health care delivery and cost of care.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Ferritin reduction to 25 ng/ml by phlebotomy
VA Medical Center, Birmingham
Department of Veterans Affairs
Published on BioPortfolio: 2014-08-27T03:56:18-0400
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