The Euphas2 registry & really interesting data.....Our FDA approved EAA diagnostic / assay has yet to be even realized by the market, let alone appreciated. How much does the FDA really need to see before they put this diagnostic guided medical device / therapy ( theranostic ) into practical use? Many clinical benefits, perhaps the best of which is safety. The commercials for PMX can be as word-free when it comes to "side-effects" as the DIMI video...think of that, have you watched a drug commercial over the last 30 years? In a life and death situation the requirement for proper use and heparin administration, to avoid clotting, seems a small amount of risk for a rather large potential benefit.
As JL might say....
"So many good things my friend"!
6.4. Registry Study after EUPHAS Trial in Italy
The EUPHAS 2 study is a multicenter registry study for PMX-HP, and the aim was to verify the application of PMX-HP in the daily clinical practice (https://www.euphas2.eu accessed on 18 February 2021. Phase 1 in EUPHAS 2 involved 57 centers between January 2010 and December 2014, collecting retrospective data of 357 patients (297 in Europe and 60 in Asia) suffering from severe sepsis and septic shock caused by proved or suspected Gram-negative infection [27]. Septic shock was diagnosed in 305 (85.4%) patients and severe sepsis in 52 (14.6%). The most common source of infection was abdominal (44.0%) followed by pulmonary (17.6%). Gram-negative bacteria represented 60.6% of the pathogens responsible for infection. The survival rate of 28-days was 54.5% (60.4% in abdominal and 47.5% in pulmonary infection). Patients with abdominal infection treated with PMX-HP within 24 h from the diagnosis of septic shock had a 28-day survival rate of 64.5%. This number was comparable with 68% observed in the EUPHAS study [17]. There were no life-threatening adverse events related to PMX-HP and the feasibility of PMX-HP application was confirmed. The blood endotoxin (EA value) was measured in 132 out of 357 patients (37.0%). The measurement was possible in 18 out of 24 centers. A median EA value at the time 0 was 0.77 (0.69–0.90). The EA value of ≥0.6 was in 120 patients and less than 0.6 in 12 patients. This means that 90% (120/132) of the patients whose EA value was measured had a high value. Endotoxemia may be accompanied frequently in this patient’s population. Phase 2 in the EUPHAS 2 registry has been ongoing since 2015