Main Study News
This first part of 2020 has been somewhat different than normal, and we have experienced a pandemic that has overloaded the ICU around the world. DISCO was set on hold because of this situation in the end of March, to spare the hospital personnel the extra pressure that the study would bring.
Some sites are still struggling with COVID-19 but the good news is that some sites has seen a decrease of COVID patients and are planning on starting up the study again during or after the summer.
Another good news is that Holland has started their first site in Radmoud and included their first patient in the beginning of June.
We hope that the stream of COVID-19 patients will continue to decline so that the world can go back to normal and studies can start up again.
One year has passed and we have recruited a total of 90 patients in the main study and we now have a total of
168 patients in the DISCO study.
The Netherlands and France are working on their applications to the ethics committee so that they can start up DISCO.
We are glad that all sites were represented at the investigators meeting in November and a lot of important issues where discussed.
At this meeting it was decided that the IQ-CODE at ICU no longer will be used.
A newsletter, that has been sent to all sites, can be downloaded from our webpage with more information.
Since we started the main study we managed to reach 40 patients just before 2018 ended!
Patient number 40 was included in the study only 2 hours before the new year.
Well done everyone, let's keep up the good work and include more patients in 2019
A new version of the Protocol (v2.2 180413) has been sent to every participating site and we ask
site investigators to read it and sign at page 6.
There has been some restructuring of the text and our statistician has done some clarifications in the statisics chapter.
The new version can also be downloaded from our homepage. A newsletter has also been sent to participating sites.
The study is up and running and so far so good.
There has been some changes in some of our documents:
All of them are marked with a red text "new version" for at least one month so that you will know whats new.
FAQ is under construction still, and a news letter will arrive before summer.
Our initial plan to start the main study on the 15th of March 2018 has unfortunately been postponed until
15th of April.
The reason is that our work to complete “clean file” of the pilot phase has been delayed.
Also, some adjustments of the main study protocol are awaiting to be approved by the
Ethics Review Board. We know you are eager to start and I am sorry for this delay.
However, everything needs to be in place before we can start, which I hope you all understand.
Please contact me if you have any questions regarding this or any other issue.