Some months after the randomization was revealed, a shareholder emailed Dr Chan about it, this was what he stated, "We can only speculate on what happened. One of the things hypothesized by some clinicians in the trial was exactly what you mention. That there may have been a belief that CytoSorb treatment could help these very sick patients. Another reason could be more practical. In order to use CytoSorb therapy, a temporary dialysis needs to be inserted into a major vein in the patient. Patients who are already getting dialyzed for renal failure already have a temporary dialysis catheter in them, making it easier to enroll these patients into the treatment arm. Unfortunately, either scenario leads to bias, which is why we saw a more than 3-fold difference in the incidence of renal failure (57% vs 17%, p=0.05), prior to enrollment, in the treatment arm that was statistically different. Electronic randomization helped to correct this issue."
When reading about CytoSorb usage below, you can get a sense why the randomization issue occurred. Add on the doctors expressing interest in participating in the dosing study, up to 18 doctor initiated studies and case reports being generated for the patient registry.
* Zacks: "Indications are that early feedback relative to safety and efficacy is very encouraging. As an example, the company notes in a recent investor presentation specific instances where CytoSorb was credited with helping save the lives of critically ill patients. Also of significance is that while CytoSorb has largely been used in instances where the patient is so critically ill that there's little to lose by trying the device, with the recent additional confidence of its efficacy this is now starting to progress where the device is being introduced at an earlier stage of intervention (another sign of substantial support, in our opinion)."
* Jan SHL 2013: "Outside of the trial, in every day clinical practice, physicians have had generally encouraging results with CytoSorb®. For example, there have been a number of cases of septic shock and multiple organ failure where CytoSorb® was used in patients with extremely high cytokine levels (e.g. IL-6 greater than 20,000 pg/ml). These patients were extremely sick with a variety of infections ranging from a Streptococcal limb infection to suspected gram negative sepsis following complications from a gynecologic procedure. In each of these cases, the prognosis was reportedly grim by the treating physicians. With CytoSorb® treatment, IL-6 levels dropped dramatically over the course of several days, with an eventual resolution of organ failure, and patient recovery. Based upon feedback from these physicians, they are interested in documenting these surprising results for potential publication."
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