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Principal Investigators

Thanks to all Participating Centers and collaborators for engaging in this research program!

Thanks to the CCCTG for endorsing this research project.

Thanks to the CNTRP for their precious contribution.

FAQ for research staff

Frequently Asked Questions (FAQ)

General Questions

Q: A DCD patient had all of their organs declined and is no longer considered an organ donor. Do I still keep patient enrolled and record data even though they are now a straight withdrawal of life support?
A: YES! We will capture data for all consented organ donors, regardless of whether they go on to donate organs or not.

Q: The patient consented for organ donation today, what study day does this correspond to?
A: This corresponds to the day of consent (C). You can now collect retrospective data from the day prior (C-1) and prospective data for all days that follow (C+1, C+2…) until organ recovery.

Q: Other studies I have been involved with us 8:00 am to 8:00 pm as the study day, is this true for DONATE?
A: Unfortunately, no. Because all of the data for DONATE is recorded in reference to the day of consent (a calendar day) we decided to make all data correspond to the calendar day. We apologize for any inconvenience.

iDataFax Questions

For questions regarding iDataFax, please see solving and minimizing queries document.

Q: I have adjusted the data on a CRF to solve a query but the field is still blue, what do I do?
A: Once you have adjusted the data to solve a query and you save the page as ‘incomplete’, a pop up box should appear to say, you have resolved a query and may not be able to sign off as final. Once you acknowledge this message you should have the green final button appear. IF NOT, please do not respond to the query. Instead contact the methods centre for assistance.

Q: I have entered all fields on a page, there are no queries, and I still cannot sign off as final. What’s up?
A: There may still be some bugs in the system. If this happens please contact the methods centre for assistance and they will address the issue.

Q: I have entered a lab test result that I know is a true value but DataFax is telling me it is out of range. Why?
A: The ranges we have entered into iDataFax are based off of past experience and may not be 100% accurate for organ donors whose values may be very out of range compared to typical ICU patients. In this case please contact the methods centre to have the range adjusted.

CRF Questions

Q: Concerning glycemic blood work (Form 20.1). If the glycemic lab at 00:00 h and 03:00 h are above 8 mmol/L can I assume the “cumulative number of hours glucose>8 mmol/L” is 3.0 hours?
A: As long as there are no other glucose measurements available within this three-hour time span, yes. Count the estimated time above or below glucose thresholds as out of range until there is a normal blood result.
    For example, If there was a normal result at 01:30 hours and again at 07:00 hours, the cumulative number of hours >8 mmol/L would be 5.5 hours. That is 1.5 hours from 00:00h to 01:30h and 4 hours from 03:00h to 07:00h for a total of 5.5 hours.

Q: Concerning Daily Data Form 4.2, Q13, 14 & 15. Do we record only episodes above 10 minutes?
A: All episodes of arrhythmia, hypotension and desaturation per day have to be recorded. If 3 episodes of hypotension occur for example, then “3” should be entered on the Daily Data Form and 3 Hypotension Forms (Forms 23.1 – 23.3) should be completed. The 10-minute definition refers to hypoxemia/desaturation. Any arrhythmia requiring intervention should be reported and any hypotension that lasts more than 5 minutes.

Q: In reference to Daily Ventilation Form 5.1 Q10. We do recruitment maneuvers but we do not have a written and approved protocol in our centre. Do we check “Protocol for organ donation” because the maneuver is being done for the purpose of organ donation?
A: If it is not a protocol (written and approved by a committee), this should not be reported as a “protocol for organ donation”. Instead check off “Other” and specify “informal recruitment protocol”.

Q: Concerning vasopressin, it is often given before consent for organ donation. Do we write the date of the beginning of the perfusion even it if before the organ donation consent?
A: Yes. You should write the date the perfusion was initiated, even if it is started before consent for organ donation.

Q: Concerning the Coenrolment Form 34.1, and the question of “Informed Consent Required?”. As DONATE consent is implicit, how do we fill this section. For example, a study about kidney grafts has a deferred consent (specimens are collected from donors at arrival or at time of consent for donation). If the family consents to research during the time of consent for donation with the OPO, the specimens proceed to analysis. As a result, the time of consent for this study is often when we will out the formal written consent. How would you answer for this study.
A: Considering that the formal/signed consent for organ donation confirms enrolment in DONATE, and that the consent for the mentioned study also occurs at the time of formal consent, you should check off “3 = Yes, SAME TIME AS DONATE”.

Questions for Quebec Sites

Q: Where it is written “local organ donation coordinator”, who does this refer to? The local organ donation nurse? Or the Quebec Transplant Coordinator?
A: This refers to the local organ donation nurse (AKA infirmiere-ressource).

Q: When patients are transferred from other hospitals, there is a lot of missing data (labs, vital signs etc.). How do I handle this situation?
A: Try to collect as much missing data as you can. If something is missing, you can mark it as missing in iDataFax. Make sure to answer “yes” to Question 8 on Form 1.1 “Was patient transferred to this hospital strictly for donor management?”.

Questions for Ontario Sites

Q: I received a notification from the Methods Centre that there is a consented donor at my site. Is this confirmation that a formal consent for organ donation was obtained?
A: Yes, the automatic notifications from TGLN are sent to the methods centre once the formal consent is entered into their database.