The Data Coordinating Center (DCC) for the Hemodialysis Vascular Access Clinical Trial Consortium (HVACTC) will coordinate the scientific and operational aspects of a series of clinical trials. This consortium will design and conduct multicenter, randomized, placebo- controlled clinical trials of drug therapies to reduce the failure and complication rate of arteriovenous grafts and fistulas in hemodialysis patients. In the planning phase (Phase I), the DCC, in conjunction with the HVACTC, will design and develop protocols and data forms for each of the individual trials. A detailed proposal is suggested for the initial trial. Systems for data acquisition (via a secure web-based data entry) and data management will be established. A major activity of the DCC will be the development of procedures for enhancing the quality and completeness of the data collected. A detailed Manual of Operations will be developed describing the data collection procedures and other procedures for the Clinical Centers. The randomization schedule for entering patients will be generated. The DCC will provide centralized training of Clinical Center staff on the entry of trial patients, the completion of trial forms, and the use of the data management system. The DCC will arrange and actively participate in meetings and conference calls of the Steering Committee and its subcommittees. A major function of the DCC during the Recruitment and Follow-Up (Phase II) of each trial will be to monitor patient recruitment and compliance as a whole and by Clinical Center. The database management system developed in Phase I will be used to assure accurate and complete collection of trial data. An inquiry system will be used to resolve data discrepancies. Trial progress will be reported in monthly reports to the Clinical Centers, and reports to the Steering Committee and Data and Safety and Monitoring Board. Statistical and interim analyses will be performed during the course of each trial with final analyses completed and reported in Phase III. The DCC will develop new statistical methodology as needed to properly analyze the data being collected. Since the HVACTC is a multi-centered effort on several trials, the DCC will provide leadership to coordinate the trial designs and the conduct of the respective trials to optimize the efficiency of the information gained by the complete series of trials undertaken. The DCC will work to foster a spirit of cooperation which is important in this consortium.
| Dixon, Bradley S; Beck, Gerald J; Dember, Laura M et al. (2011) Use of aspirin associates with longer primary patency of hemodialysis grafts. J Am Soc Nephrol 22:773-81 |
| Dixon, Bradley S; Beck, Gerald J; Vazquez, Miguel A et al. (2009) Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med 360:2191-201 |
| Dember, Laura M; Beck, Gerald J; Allon, Michael et al. (2008) Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA 299:2164-71 |
| Dixon, Bradley S; Beck, Gerald J; Dember, Laura M et al. (2005) Design of the Dialysis Access Consortium (DAC) Aggrenox Prevention Of Access Stenosis Trial. Clin Trials 2:400-12 |
| Dember, Laura M; Kaufman, James S; Beck, Gerald J et al. (2005) Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials 2:413-22 |
