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Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD. Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD. conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD. Clinical research trials and Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD. healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD.. Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD. Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD. clinical trial. Subjects frequently obtain the most expert healthcare possible for their Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD. condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD.  Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD.
Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD.
For Condition: Intermittent Claudication,Atherosclerosis,Reduction of Total Body Iron Storage(TBIS)
Status: No longer recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: Patients with PVD.
Total Enrollment: 1600
Location and Contact Information:
Gainesville VA Medical Center
Gainesville, Florida, 32608-1197
United States
Long Beach VA Medical Center
Long Beach, California, 90822
United States
Hines VA Hospital
Hines, Illinois, 60141
United States
Houston VA Medical Center
Houston, Texas, 77030
United States
Wm. S. Middleton Madison Veterans Hospital
Madison, Wisconsin, 53705
United States
Salt Lake City VA Medical Center
Salt Lake City, Utah, 84148
United States
West Haven VA Medical Center
West Haven, Connecticut, 06516
United States
Louisville VA Medical Center
Louisville, Kentucky, 40206
United States
Lexington VA Medical Center
Lexington, Kentucky, 40511-1093
United States
Little Rock VA Medical Center
Little Rock, Arkansas, 72205
United States
Leavenworth VA Eastern Kansas Health Care System
Leavenworth, Kansas, 66048
United States
Cleveland VA Medical Center
Cleveland, Ohio, 44106
United States
New York VA Medical Center
New York City, New York, 10010
United States
San Juan VA Medical Center
San Juan, , 00921-3201
Puerto Rico
Durham VA Medical Center
Durham, North Carolina, 27705
United States
Albany Stratton VA Medical Center
Albany, New York, 12208
United States
Milwaukee Zablocki VA Medical Center
Milwaukee, Wisconsin, 53295
United States
VA Pittsburgh Health Care System (UD)
Pittsburgh, Pennsylvania, 15213
United States
Birmingham VA Medical Center
Birmingham, Alabama, 35233
United States
VA Palo Alto Health Care System
Palo Alto, California, 94304
United States
Reno VA Medical Center
Reno, Nevada, 89520
United States
White River Junction VA Medical and Regional Office Center
White River Junction, Vermont, 05009
United States
Additional Information:
Study ID Numbers: 410;
Study Start Date: October 1998
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032357
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Does the reduction of Total Body Iron Storage (TBIS) alter mortality in a population of patients with advanced PVD.
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