EUPHAS 2 is a patient registry for the collection of clinical data from patients undergoing polymyxin B hemoperfusion therapy (Toraymyxin®).
Data of 357 patients treated during the first phase have been published recently in Annals of Intensive Care Medicine.
- 357 patients were treated with Polymyxin B heoperfusion.
- The main focus of infection was abdominal (44%) followed by pulmonary (17.6%), cardiac (6.4%), trauma (5.3%) and urinary (4.5%)
- A significant improvement of cardiovascular SOFA score, respiratory SOFA score, renal SOFA score at 72h from baseline and an overall 28-day mortality of 54.5%.
- Dividing the population according to infection focus, 28-day survival in abdominal patients were 60.4%, compared to 47.5% in pulmonary patients.
- In the abdominal patients, when the treatment was performed within 24h from the diagnosis of septic shock, 28-day survival was 64.5%, similar to the results obtained in the EUPHAS study (68% but in a patient population of 34 patients, JAMA 2009)
- Patients who showed a reduction of cardiovascular SOFA score of at least 1 point at 72 h from baseline, had a 28-day survival of 75%.
- The study confirmed the safety and feasibility of Polymyxin B hemoperfusion.
Toraymyxin® was marketed in Japan in 1994 and in Europe in 1998. The specific therapeutic target is the patient with endotoxin-mediated septic shock who is unresponsive to standard therapy. Outside Japan, Italy is the primary user of Toraymyxin®.
This therapy gradually gained acceptance in the scientific community, as the amount of evidence increased from initial small clinical studies, to a carefully conducted systematic review in 2007, and finally to a multi-center randomized clinical trial (RCT) conducted in Italy, the EUPHAS Study, published in JAMA in 2009.
Despite the importance of RCTs, the patient selection criteria defined in a study sometimes represent biases. Furthermore, given the substantial number of patients treated with PMX-HP, there is an increasing need to study the use of Toraymyxin® in the current clinical practice by tracking patient data.
In 2010, an international group of investigators launched the project EUPHAS 2, a multi-center, collaborative study, aiming to create a large database concerning Toraymyxin® treatment. The scope is to evaluate the effectiveness and biological significance of endotoxin removal in the clinical practice.
Additionally, this project aims to verify the reproducibility of the data currently available in the literature, evaluate the patient population chosen for treatment and identify subpopulations of patients, who may benefit from this treatment more than others.
Type of study: Observational cohort study
Phase 1: Retrospective data collection (January 2010 – December 2014)
- To obtain data from a least 250 patients. The data from this phase were used to define the data collection criteria for the second phase.
The first interim publication of data obtained from January 2010 to July 2013 of 306 patients from 31 hospitals was published in January 2014 in Blood Purification.
The second publication on data obtained from January 2010 to December 2014 of 357 patients from 35 hospitals was published in 2016 in Annals of Intensive Care Medicine.
The indications provided by the first phase, led to the development of the second prospective phase, aimed at a more complete and intuitive collection of data.
Phase 2: Prospective data collection (January 2015 – open)
- To strengthen the knowledge of the decision-making process leading to therapy prescription and to evaluate the effectiveness of the therapy.
- To identify subpopulations of patients who may benefit from this treatment more than other
To participate: www.euphas2.eu