RE:Coincidence ?Reference link to Japanese Study
https://pubmed.ncbi.nlm.nih.gov/34568980/
mercedesman wrote: Sept 26/2021
Effectiveness of polymyxin B hemoperfusion for sepsis depends on the baseline SOFA score: a nationwide observational study
...Of 44,177 patients included in the study, 2191 received PMX... Conclusion: Analysis of a large-scale Japanese inpatient database found a significant association between PMX efficacy and baseline SOFA score. This result indicates higher efficacy in patients with medium SOFA scores in the range of 7-12. The result provides a promising hypothesis for selecting appropriate patients for PMX and should be validated in future RCTs. * * *
Nov 29/2021
Dr. John Kellum, Chief Medical Officer of Spectral, commented, “We are very pleased with the FDA approval of our Tigris protocol amendment to allow the use of SOFA, which is an alternative scoring system used to quantify severity of illness. Adding SOFA as an alternative to capture cardiovascular dysfunction when it is already being treated by vasopressor drugs removes a critical barrier to enrollment using MODS and harmonizes the study protocol with current sepsis guidelines and practice patterns across most hospitals. We are very excited to implement SOFA into the study as we believe it should have a significantly positive impact on enrollment. We estimate enrollment will increase by 25% to 50% using SOFA.”
“The ability to include patients based on SOFA scores removes a major barrier to enrollment in Tigris,” said Dr. Ali Al-Khafaji, Professor of Critical Care Medicine at the University of Pittsburgh School of Medicine. “While our site has enrolled patients based on MODS, the ability to now enroll patients based on SOFA should have a material impact on our enrollment rates. I would expect this enrollment impact to be universal across other Tigris sites, and should greatly reduce the time needed to complete the trial.”
https://stockhouse.com/news/press-releases/2021/11/29/spectral-medical-announces-u-s-fda-approval-of-tigris-trial-protocol-amendment
Let's see if they are correct !
MM