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 Azeptic Trial
Update
Issue 10, December 21, 2007
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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.
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Monitoring Visit Schedule
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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 |
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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.
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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.
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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!
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