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Azeptic Trial Update
Issue 9, November 20, 2007

Thanksgiving Image

Welcome


Welcome to Dee Scanlan!
Dee started working on the Ash Study as the Averion Clinical Project Coordinator in September and has been a great help. Please be sure to email her your enrollment logs each week! Her contact information is below:
Phone: 508-597-5939
Email: Dorothy.scanlan@averionintl.com


Welcome to our Newest Study Sites:
Dr. Shetye—Clearwater, Florida
Dr. Bernardo—Houston, Texas
Dr. Germain—Springfield, Massachusetts
Dr. Strom—Boston, Massachusetts


A special thanks to Dr. Cooper’s site in Phoenix, Arizona. They have enrolled 29 patients since starting on the trial in August! This is a new trial benchmark!


Monitoring Schedule/CRF BackLog/Outstanding Queries

Our monitors are working hard to catch up with the CRF review and collection at all sites. Please make sure that you have completed all outstanding action items and have caught up on your CRF completion prior to your monitors scheduled visit. We are trying to get to all the sites every four weeks and appreciate all of your assistance in allowing us to follow our monitoring timelines. All DCFs received from StatKing should be completed and returned to StatKing within 7 business days of receipt. Please make sure you are completing the queries as soon as possible so that we can continue to keep our databases updated.

Enrollment Update

  • We are in our final push for enrollment. We have 29 patients left to go and are counting on you to help us reach our goal of completing enrollment by December 31, 2007.
  • It is more important now than ever to make sure you are sending in your updated enrollment logs each week. This is the only way we will know if we have reached our goal.
  • Once enrollment has been completed, we will be notifying you via fax and email, so until then, please keep enrolling!
  • We appreciate all of the work you are doing to continue screening/randomizing patients, so please keep it up!

Enrollment Progress As of 11/20/07
Please remember to send in your enrollment log each Friday
Dr. Hariachar, Hudson, FL (101)
42
Dr. Fadem, Houston, TX (103)
8
Dr. Rogers, Ocala, FL (104)
22
Dr. Block, Denver, CO (105)
4
Dr. Kopelman, Bakersfield, CA (106)
28
Dr. Al-Makki, Lafayette, IN (107)
15
Dr. Henriquez, Bronx, NY (108)
2
Dr. Khwaja, Newport Beach, CA (109)
48
Dr. Posner, Baltimore, MD (110)
3
Dr. Roer, Waterbury, CT (111)
34
Dr. Kapatkin, Brandon, FL (112)
7
Dr. Halligan, Erie, PA (113)
20
Dr. Abbott, Orlando, FL (114)
21
Dr. Cheriyan, Fairfax, VA (115)
7
Dr. Koeper, Appleton, WI (116)
8
Dr. Herman, Buffalo, NY (117)
18
Dr. Matalon, New York, NY (118)
26
Dr. Williamson (119)
6
Dr. Shetye (121)
4
Dr. Cooper (122)
29
Dr. Besarab (123)
6
Dr. Germain (124)
2
Dr. Bernardo (125)
11
Dr. Strom (126)
0
Total Randomized
371

Fun Stuff!


The reason that we have so many myths associated with Thanksgiving is that it is an invented tradition. It doesn’t originate in any one event. It is based on the New England puritan Thanksgiving, which is a religious Thanksgiving, and the traditional harvest celebrations of England and New England and maybe other ideas like commemorating the pilgrims. All of these have been gathered together and transformed into something different from the original parts. - James W. Baker, Senior Historian at Plymouth Plantation


Name Change!!
Allie Salvi is now Allie Gorman.
Her new email address is
allie.gorman@averionintl.com.

Please be sure to contact
Rita or Allie with any study
related issues.
Rita 508-597-5773
Allie: 508-597-6223

Reminder!

Remember to document a patient’s BFR at Qb -200 arterial pressure prior to intervening with tPA or a radiologic brush if any suspected patency / flow challenges are occurring with their catheter. This number needs to be below the “patency threshold” which was calculated at the beginning of the trial and remains with the patient throughout.

 

A Word from the Sponsor

Well, here we are. Sixteen months have now passed since the first patient was enrolled in the AZEPTIC™ Trial. Sixteen months, thousands of hours of work and a strong commitment from you, our clinical study team, has brought us to the verge of completing enrollment – and we are grateful.

Our study’s total enrollment is now 371, and that number is rapidly growing toward our goal of 400. The good news is that our goal is in sight, yet we know that finishing the last 10% of any project is always the toughest. The goal is in sight – and it is clearly achievable. We know that those of you who have produced the enrollment will continue to work hard toward that end. And for those of you just coming onto the study, your responsiveness and results have been incredible. We would never be in the position we are in with this study unless you were the people “who finish what they start” and not the “so on’s” that Byrne described.

It is Thanksgiving and the holiday season, and the most important thing we can do at this time of year is to pause and be thankful for those people who are closest to us. Our family and our friends make life worth living. So let’s not let life’s hectic pace cloud that fact for each of us.

And while we are doing so, we at Ash Access are truly thankful for each of you. You have dedicated so much of yourself to reaching your site’s goals and help our company reach its goal. We understand that this has often come at the cost of your personal time with family or friends, which makes us even more appreciative.

So as we look forward, we encourage you to finish strong. Your effort to identify and enroll new patients is still needed. And just as that is before us, your diligence in the accurate, thorough and timely completion of Case Report Forms is also critical. You’ve done a great job in responding to queries, and continuing that responsiveness remains to be so important.

In turn, we hope you have seen our commitment to you throughout your time in our study, and we commit to you that our support will continue to be stronger than ever. Should you need anything to assist your effort, do not hesitate to contact us. HAPPY THANKSGIVING!

 


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!