Wasn’t Cytosorb successfully used in a well known Manhattan hospital after they got board approval? Am I remembering right? Was it used by someone on the CTSO board? Could this be done again? Would it be easier to get this done today given the changes just made federal regulations regarding hospitals?
I asked CG over on the YMB if he knew anything about this trial and got this extremely detailed response. Some good information if you like to keep track of all the studies going on. I was not aware that the WHO also keeps track of all these studies as well. Germany has a list of 5 which can be found on their trial site: https://drks.de/drks_web/navigate.do?navigationId=search&reset=true
"@Techxen, I had not come across NCT04309591 before either. I recall CTSO's 7th International Users' Meeting had several discussions of clinical trials on the agenda, but I can no longer access the original agenda now that the meeting has been postponed. Note that NCT04309591 is a retrospective study, so it's an analysis of existing clinical data, which can be completed relatively quickly. Also, most major developed countries have their own country-specific registries for clinical trials. Switzerland is one such country. In Switzerland, all clinical trials or research projects must first pass an ethics review. They have a system called BASEC (Business Administration System for Ethics Committees) for ethics submissions (https://www.swissethics.ch/basec). After ethics approval, according to the BASEC FAQ, Swiss laws mandate that all clinical research projects "must be registered and published in a WHO primary register or on clinicaltrials.gov as well as in the supplementary federal database in the form authorised by the responsible ethics committees. The Swiss National Clinical Trials Portal (SNCTP: https://www.kofam.ch/en/home/) is the supplementary federal database for research projects carried out in Switzerland." Unfortunately, the BASEC site does not seem to be directly searchable itself. The BASEC ID for NCT04309591 is listed as 2019-01740 in the "Other Study ID Numbers" field of the record on clinicaltrials.gov. Unfortunately, searching on the SNCTP portal by either this BASEC ID or the NCT ID or just the "CytoSorb" keyword does not find this trial. Searching by all trials in Basel does not find it either. Thus, clinicaltrials.gov is likely the primary registry, and there's a delay before it will show up on SNCTP. Note that clinical trials registered on SNCTP will also have an identifier prefixed with "SNCTP."
Also, note that NCT04309591 is not the first trial to appear on clinicaltrials.gov as completed. NCT04226430 is another recent one from Turkey (University of Gaziantep) -- the first for the country, I believe -- that appeared on January 13, 2020. Unlike the Basel study, the Turkish one looks to have been a prospective study that ran for 1 year from June 2016 to June 2017. I have not tried to check, but "TF.18.43" in the "Other Study ID Numbers" field is likely a Turkey-specific reference to Turkey's clinical trial system. Source: https://clinicaltrials.gov/ct2/show/NCT04226430.
While researching the Swiss clinical trial system, I also learned that WHO (World Health Organization) has a searchable database that aggregates primary clinical registries from 17 different countries. It's called the International Clinical Trials Registry Platform (ICTRP): https://www.who.int/ictrp/search/en/. It's not a perfect and does not correctly identify all duplicate registrations, but using it, I was able to find China's clinical trial record for CytoSorb and COVID-19; the ICTRP record: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030475, which links to the primary Chinese CTR record: http://www.chictr.org.cn/showproj.aspx?proj=50452.";
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