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Azeptic Trial Update
Issue 10, December 21, 2007


Enrollment is Complete!


  • Congratulations to all of the sites as we have met and exceeded our final enrollment goal!!
  • We want to thank each and every site for their contributions to enrollment. We would not have made it with out all of your hard work.
  • Please continue to send us your enrollment logs each Friday. It is important that you review your logs and make sure all completed patients and early terminations are updated accordingly on your logs to ensure that we have the most accurate information.


Monitoring Visit Schedule

  • Now that we have completed our enrollment goal, the push to pull completed CRF books is stronger than ever. Please work with your CRAs and allow them to schedule visits more frequently so that we are able to pull as much data in house over the next few months as we can.
  • Your CRA will be conducting monitoring and co-monitoring visits on a more frequent basis (as needed) to ensure we are getting as much data as possible. Your monitor will be in contact over the next few weeks to schedule additional visits if they have not already done so.
  • It is imperative to have all CRF pages caught up and all outstanding action items completed prior to each monitoring visit. This allows us to make our visits the most productive.
  • We want to thank you again for all of the hard work you have done so far. We could not have gotten here without you!

Enrollment Progress As of 12/21/07
Please remember to send in your enrollment log each Friday at ashreports@averionintl.com
Dr. Hariachar, Hudson, FL (101)
44
Dr. Fadem, Houston, TX (103)
8
Dr. Rogers, Ocala, FL (104)
23
Dr. Block, Denver, CO (105)
4
Dr. Kopelman, Bakersfield, CA (106)
32
Dr. Al-Makki, Lafayette, IN (107)
15
Dr. Henriquez, Bronx, NY (108)
2
Dr. Khwaja, Newport Beach, CA (109)
49
Dr. Posner, Baltimore, MD (110)
3
Dr. Roer, Waterbury, CT (111)
37
Dr. Kapatkin, Brandon, FL (112)
8
Dr. Halligan, Erie, PA (113)
22
Dr. Abbott, Orlando, FL (114)
23
Dr. Cheriyan, Fairfax, VA (115)
8
Dr. Koeper, Appleton, WI (116)
9
Dr. Herman, Buffalo, NY (117)
20
Dr. Matalon, New York, NY (118)
28
Dr. Williamson (119)
6
Dr. Shetye (121)
6
Dr. Cooper (122)
36
Dr. Besarab (123)
7
Dr. Germain (124)
3
Dr. Bernardo (125)
16
Dr. Strom (126)
8
Total Randomized
417

CRBSI & Patency Reminders

It is important to remember the steps to take if there is a suspected CRBSI or Patency Issue.

  • CRBSI: Blood Cultures should be drawn for patients who are experiencing ANY signs/symptoms of an infection.
  • Blood Cultures should be sent to DaVita Labs and a CRBSI worksheet should be filled out and sent to the Blinded Evaluator if the cultures come back positive.
  • Patency: If a patient is having Patency problems during treatment, staff should document the patient’s BFR at –200 arterial and administer TPA or Radiologic Procedure if necessary when the BFR is deemed to be below the patient’s Patency Threshold.
  • The Patency Failure Worksheet should be completed and sent to the Blinded Evaluator if the patient’s BFR did not go back up above the Patency Threshold, following the attempt of at least one but not more than three consecutive interventions per incident. The patient’s catheter should then be pulled.

Medical Monitor Phone Number: (765) 413-7676
All questions regarding Inclusion/Exclusion criteria compliance, potential adverse device effects, patient safety, and other medical issues related to the study should be referred to the Medical Monitor.
 

Since you are reading this page, you are already aware of the Clinical Trial page on this website. Make sure you notice that the Clinical Trial page contains all issues of the study newsletter, a PDF of the trial poster and local newsletter example, site contact information, Q&A log, and CRF re-order form. Please contact Averion or Ash Access if you think of any useful additions to the website, or have any feedback!