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Question Answer
Labs  
Is adjusted calcium the same as corrected calcium? Yes
Clinically Significant vs. Not Clinically Significant on the labs. The determination must be from the PI, and should be consistent.
Where is DaVita's laboratory? It is in Florida. Overnight delivery is to be used, and Sunday delivery is available if pre-arranged.
How is Kt/V measured? Standard lab.
Will off-site labs need to be added to the FDA form 1572? This is a device study, so there is no FDA form 1572. Please just use the lab cultures and results, which usually include the normal ranges.
Device  
Study Device came in a box with 75 vials. The inventory receipt that came from PSI indicated “1 box”, but did not indicate the number of vials. The coordinator should add the number of vials received to the receipt information and sign/date the form and fax it back to PSI as directed on the form.
Are there any known allergies to the AAT-023? No
May the empty devices be discarded after use? They may be discarded after the Averion monitor has performed device accountability.
How could an overdose occur? An overdose is unlikely, but the sponsor will reimburse for a supply of calcium gluconate, the antidote for an overdose.
Can the site be provided with separate containers for each person for device accountability? This is not possible due to the potential for waste.
Are temperature logs to be maintained? This is not necessary. The device is to be stored at 59º-86ºF; please observe these ranges when transporting devices to satellite sites.
Will drug accountability be performed for heparin? No.
Will the vials of the device contain overfill? If so, can this be used? Or would another vial need to be used to get the extra amount of device? The actual fill volume is 5.3ml in each vial. Yes, all of that volume may be used. This volume should cover all catheters.
Protocol  
Prohibited Therapy- Protocol says: “All medication (antibiotic therapy) for signs and symptoms of CRBSI are not allowed for 30 days…” Is this just antibiotics related to s/s of CRBSI OR is it “all antibiotics” for any reason. All antibiotics
Can subject with dementia be enrolled if a spouse signs the consent form? No
How recent is “recent transplant”? Physician discretion.
The protocol states that the HD machine number is to be captured. The source and CRF ask for machine type and serial number at each treatment day. Can we use the machine number (2 or 3 digit number) instead of the serial number? The dialysis machine number, not the serial number will be captured. The source document template has been updated to reflect this. The CRF, however, still says "serial number".
How are protocol deviations/exceptions to be handled? Fax the Protocol Exception Form to the study medical monitor, Linda Francisco, MD, at 316-636-5019.
Are the dialysis nurses giving the solution required to sign the delegation of authority log? And if yes, do we need to obtain as per log their CVs/licenses? Yes, they are required to sign the Delegation of Authority Log. For the staff at DaVita sites who have been trained, a Note to File will be acceptable in the place of CVs.
Will dialysis technicians that give the heparin need to be on the delegation log? Since this is the standard of care, I'm thinking no.
Can an Advanced Nurse Practitioner perform the study Physical Exams? Yes- NP can perform PEs.
Will the study reimburse for Activase? No
Could patients receive Corticosteroids while on study or are they prohibited meds? There is no problem with patients on the trial receiving Corticosteroids.
Is it acceptable to change Sorbaview or Tegaderm at the exit site weekly, rather than at every dialysis? Yes.
What if your site does not have curtains for ensuring sterility during hemodialysis? Every effort is to be made to maintain a sterile dialysis environment, but you are not required to provide an environment not normally provided, as long as the standard of care for aseptic dialysis is met. Please add a Note to File in your regulatory binder describing your normal standard of care for hemodialysis. (Appendix G to the protocol specifies use of a drape or curtain, so the note is necessary to document the standard procedure that will be followed at your site.)
If the patient presents afebrile but reports having been febrile prior to the visit, or subsequent to a previous visit, and the site's normal practice in these circumstances is to take samples and culture them, and the samples come back positive despite the patient's having been afebrile at the time of taking the sample, what should the site do? First, do not administer antibiotics prior to taking the samples. Second, if samples were taken while the patient was afebrile but came back positive, call the medical monitor, Linda Francisco, MD..
May the peripheral blood samples be arterial? Yes, if the HD machine is running.
How many attempts at the peripheral draw are required if the draws are not successful? Follow your normal standard of care for that patient at your site.
Should a patient whose standard of care is to receive tPA at every hemodialysis be enrolled? At this point in the study, the patient should not be enrolled. Prior to intervention, sub-threshold BFR must be reached, and tPA is considered intervention.
Is the screening average BFR pre-dialysis? Yes.
Are there any prohibited concomitant medications? There is no list of prohibited or contraindicated medications. If you have a question about the appropriateness of a concomitant medication for a study patient, please call Dr. Francisco at 316-841-4956.
Is there any problem or consequence if the site is not able to aspirate the Ash solution out of the catheter and if it is pushed into the catheter? Are there any steps the sponsor would like followed for the safety of the patients when this occurs? The product is designed to be safe even if fully injected, yet extreme care must be taken in this event. Extend the close observation time to 30 minutes (rather than 10 as specified in Protocol section 4.5.2.4.5). This should be recorded as a protocol deviation and reported to the IRB. However, if the subject experiences an adverse device effect, the event should also be recorded as an ADE. Should this be recorded as an ADE irrespective of whether patient experienced any effects?
How are the hemodialysis cumulative blood flow averages to be calculated, given that the pressures change as needed rather than at regular increments? It is expected that the average blood flow rate will be taken from the machine following treatment. If this value is not automatically calculated by the machine, manual instantaneous blood flow rates should be taken at equal time intervals and then manually averaged across the treatment.
If RNs prefer that individuals with mature venous catheter access do not wear dressings, what is ASH’s stance on this? This should be deferred to the medical monitor and/or PI for determination. Once a determination is made, it should be clearly documented in the subject's progress notes.
CRFS  
Are there extra Medical History and Concomitant Medication Forms for the CRFs? Yes.
How much medical history is to be captured? Only significant medical history? Yes, significant medical history -- ie.., a tonsillectomy that was performed in 1975 wouldn't necessarily be considered 'significant'.
What surgical history is required? For example, only major surgery in the past ten years? Yes. Significant surgical histories should be recorded, i.e., CABG, nephrectomy, etc., are significant - tonsillectomy, not necessarily significant.
Are herbal remedies to be recorded on the concomitant medications CRF page? Yes, please record all concomitant medications, route and indication
On CRF page 17 (and any corresponding pages), if fewer than three interventions are performed, should the site line through, date, and initial the unused data fields? Yes
Do CRFs need to be completed for screen failures? No. CRFs do not need to be completed for Screen Failures. They do need to be completed for patients randomized who refuse treatment. See the Randomization Procedures for a list of theses CRFs.
Safety  
Are serious device effects to be reported to WIRB? Investigators must notify their IRBC only of any Unanticipated Adverse Device Effects that occur during the study.
What is the definition of a hospitalization? An overnight stay.
Subject Participation  
May a study patient be in another study if that other study is observational only? Yes, if there are no blood draws, or the blood draws are only normal blood draws.
May a study patient be in another study if that other study draws blood at 6 and 12 months, and involves an approved medication? No.
Training  
I was wonder if you have a site training log/form that I could circulate to get all the RN’s to sign (for those who went to Amy’s training). I would suggest doing a note to file with a brief description of the training covered. The staff should then sign (print name, signature & date).
What materials should I use or give to RN’s that I still need to train and what form should I use to document their training? At a minimum, I would do a brief overview of the protocol (just so they know the primary and secondary endpoints) and a detailed review of the CRBSI and Patency Failure evaluations along with the worksheets. You could use the same materials that are in the Initiation Binder. If you need further help with this, we can chat prior to your training sessions.
Do we have an abbreviated or quick reference for collection of blood cultures and exit site cultures that I can use to post in the dialysis units for the RN’s so if we are not around so they don’t have to root thru the protocol? I have actually put together a few 'cheat sheets' -- Roland has them for review. As soon as I get them back, printed and laminated, we'll be sending to all the sites for their use.
Do you have a copy of DaVita’s SOP for dressing changes? I thought we could have all the individuals who do dressing changes sign it and I could keep it in the files as proof of training. Unless it’s not necessary. I just don’t want to go back and try to get training records retrospectively.
Misc  
Do we really want to require both the screening number and the patient number (randomization) considering how many entries that there will be? There is only a patient number- there is no screening number. The Enrollment log has been updated to reflect this.
Will the coordinator be at each and every dialysis treatment for 6 months to “dispense” the solution or will the dialysis nurse obtain the solution? The dialysis nurse can administer the device. Be sure that any staff participating in any study activities is on the Delegation of Authority Log and a signe/dated CV and license are filed.
Further clarification is needed and the forms need to be consistent in what they say regarding randomization. The protocol/protocol review slides state that eligible patients will be randomized as close as possible to the first study HD. Information on the randomization process state that randomization cannot take place until the subject is present in the dialysis center. It is strongly suggested that a patient be randomized while they are at the site in order to avoid losing randomized patients as no-shows, etc. Once a patient is randomized, they cannot be re-randomized and withdrawals will not be replaced.
Could each site have pocket-sized laminated instructional cards with the CRBSI and Patency Failure information? Averion has put together "cheat sheets" for the dialysis staff and will distribute these to each site.
Will Informed Consent Forms be available printed in Spanish? Yes, these will be provided. Once the IRB has approved the consent form, it will be translated into Spanish and sent to the sites.
How are the dialysis machines to be calibrated? Per the manufacturer's instructions.
FYI  
On the Study Completion Form (and source doc), it lists a reason for withdrawal as "Subject received 3 consecutive HD treatments off-protocol". This should be "more than 3".
Reminder: When drawing catheter blood for cultures do NOT use the same syringe when drawing blood from the lumens due to the possibility of cross-contamination. After drawing the blood from both lumens into two separate syringes, the specimen is split between the two bottles for analysis - aerobic and anaerobic (ie., half of vial 1 and half of vial 2 is put into bottle #1; the remaining blood is put into bottle #2).