Zuragen™ Clinic Poster
Local Article Example
Q & A
Educational Incentive Program
CRF Re-order Form
CRF Helpful Hints
Hemodialysis Catheter (Material) Types
Temperature Conversion Chart
Issue 7, June 15, 2007
Tip of the Month
When to complete the worksheets?
- Patency Failure: IF the patient's BFR goes below the patency threshold AND at
least one, but not more than three interventions are performed AND the BFR does
NOT go above the established threshold. Fax a copy of the worksheet to the
- CRBSI: IF the patient has a suspected CRBSI and a blood sample is drawn from
BOTH the catheter and peripheral vein OR catheter and exit site sample. Fax a
copy of the lab results along with the worksheet to the Blinded Evaluator.
Hints & Tips to Avoid Queries
- Please do NOT use abbreviations on Medical & Surgical History, Physical Exam or
Concomitant Medications pages (i.e. you will need to spell out ‘hypertension’ vs.
HTN). This helps to eliminate a lot of guesswork on the part of the Data Entry
- You need to record AT LEAST the YEAR for start/stop dates for Medical & Surgical
History, Physical Exam or Concomitant Medications. UNK/UNK/UNK is NOT
acceptable to the FDA!!!
- Documentation for amount of catheter lock used: if the patient is randomized to
ZuragenTM (AAT-023), please record the total amount of ZuragenTM required to fill
the catheter lumens plus .3 overfill. If randomized to heparin, please record the
5000 u of heparin PLUS the amount of normal saline used to the fill volume of the
catheter lumens. BOTH NEED TO BE RECORDED IN YOUR SOURCE
DOCUMENTS (i.e. dialysis flow sheets, progress notes, etc.) as well!
PLEASE be sure to discuss the AZEPTIC trial with your dialysis staff and provide
appropriate guidance to assure the protocol is being followed. If additional in-service
trainings are needed, please contact Rita, Allie, or your monitor.
New Site Updates
Enrollment Progress As of 6/11/07
Please remember to send in your enrollment log each Friday
|Dr. Hariachar, Hudson, FL (101)
|Dr. Stephanz, (102)
|Dr. Fadem, Houston, TX (103)
|Dr. Rogers, Ocala, FL (104)
|Dr. Block, Denver, CO (105)
|Dr. Kopelman, Bakersfield, CA (106)
|Dr. Al-Makki, Lafayette, IN (107)
|Dr. Henriquez, Bronx, NY (108)
|Dr. Khwaja, Newport Beach, CA (109)
|Dr. Posner, Baltimore, MD (110)
|Dr. Roer, Waterbury, CT (111)
|Dr. Kapatkin, Brandon, FL (112)
|Dr. Halligan, Erie, PA (113)
|Dr. Abbott, Orlando, FL (114)
|Dr. Cheriyan, Fairfax, VA (115)
|Dr. Koeper, Appleton, WI (116)
|Dr. Herman, Buffalo, NY (117)
|Dr. Matalon, New York, NY (118)
|Dr. Williamson (119)
|Dr. Shetye (121)
|Dr. Cooper (122)
Flag Day was first observed in 1877 on the 100th
anniversary of the Continental Congress' adoption of the
Stars and Stripes as the official flag of the United States.
In that year, Congress asked that all public buildings fly
the flag on June 14. The idea quickly caught on and many
people wanted to participate in waving the flag. One early
supporter was B. J. Cigrand, a Wisconsin schoolteacher
who wanted June 14 to be known as "Flag Birthday."
In 1916, President Woodrow Wilson proclaimed Flag Day
as a national celebration. However, the holiday was not
officially recognized until 1949 when President Harry
Truman signed the National Flag Day Bill.
Helpful Tips from StatKing
- Queries will be sent to study sites on
Thursdays for arrival to your site on Friday.
The queries will be sent out every other week.
The most recent set of queries were sent out
on June 14, 2007.
- Please remember to check if a medical history
captured on the Baseline Medical History
Form is resolved or ongoing.
- Don’t forget to check the frequency and
intensity of a sign/symptom if yes is checked
for a sign or symptom experienced during
dialysis on CRF pages 11-13 Baseline—
Common Symptoms Experienced during
- If you answered no to the question of CRF
page 17.__ Hemodialysis Treatment Form—
Part I “Patency Failure?” You do not need to
answer the question “If yes, was the patency
failure confirmed by Central Blinded Evaluator.?”
- If a protocol exception is granted, please make
sure to record the name of the medical
monitor contacted under the “Medical
Monitor Contact” on CRF page 6.
The AVERAGE of the most recent three Blood
Flow Rates just prior to randomization must be
over 300. For example, if a patient was
randomized on 6/11/07, and the three previous
treatments had an average BFR of 265, 340 and
315, the average of the three is 306 and the patient
would be eligible for the study.
Please be sure to re-screen any patients who may
have been affected by this clarification.
If you have any questions, please contact Rita or Allie at Averion.
Happy Summer!!! We hope you are looking forward to warmer
weather, longer days, upcoming vacation plans and of course,
completing enrollment in the AZEPTIC Trial for ZuragenTM. We
have made some nice progress in patient enrollment since the
Study Coordinator meeting in Orlando at the end of February. In
the 3 month timeframe since, we have enrolled an additional 120
patients and have approached the 250 patient benchmark. In
addition, we have worked with the FDA to add 4 new study sites
which will bring our total of sites participating in the trial to 22.
While we have much to celebrate, we still have quite a bit of
work to do over the next few months to meet our enrollment
objective of 400 patients at some point this summer. We are
really counting on all of you to thoroughly screen and randomize
“new” catheter patients entering your units or “re-screen”
patients who may have screen failed as a result of antibiotic use,
positive cultures or poor blood flows. We are confident you can
make this happen!
As you will recall from the SC Meeting, we rolled out our latest
“educational” incentive program for those sites meeting or
exceeding their enrollment target by June 15, 2007. We have
moved that date back to June 30 after personally visiting all of the
sites and hearing your feedback. We are very pleased to
announce that several study sites will certainly hit their “target”.
Stay tuned for next month’s newsletter as we announce and
highlight those particular study sites.
Finally, we want to thank you again for all of the efforts you
continue to put forth. We are well aware of the time
commitment and dedication that is required for successful
execution of our trial. We hope that you still share our
enthusiasm for the pioneering research we are all participating in
and realize the significant unmet medical need we are working to
address. We have tremendous confidence that if this trial is
successful in meeting the primary / secondary endpoints,
ZuragenTM could have significant application and potential to
improve the patient care and outcomes associated with the use of
vascular access devices across a variety of healthcare settings.
Please don’t hesitate to contact us or any member of the clinical
trial team if you have any additional comments or questions.
Ash Access Technology, Inc Team
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!