Chivasso

Myelodysplastic syndromes MDS primarily affect older adults and involve problems with blood cell production, leading to anemia, low white blood cells, and low platelets. These conditions often cause patients to depend on red blood cell transfusions and carry risks like infection and bleeding. This research evaluates luspatercept, a protein designed to help mature red blood cells, in adults with MDS who have a specific chromosome deletion del5q and who are resistant or intolerant to prior treatments like lenalidomide. The study focuses on patients with low to intermediate risk MDS and aims to assess whether luspatercept can reduce the need for transfusions. Participants will receive luspatercept injections under the skin every three weeks, starting at a dose of 1.0 mgkg, with possible increases up to 1.75 mgkg. The study has a screening period, followed by a two-year treatment phase where patients receive the drug and are closely monitored. After treatment, there is a three-year follow-up to observe longer-term effects. Researchers will track responses such as transfusion independence, hemoglobin levels, quality of life, and safety during and after treatment. Throughout the study, participants will have regular visits for assessments including blood tests, quality of life questionnaires, and monitoring for side effects. The main outcome is whether patients achieve at least eight weeks without needing red blood cell transfusions within the first 24 weeks. Additional measures include long-term transfusion independence, duration of response, reduction in transfusions, changes in iron levels, and overall safety over five years. The total participation lasts up to five years, ensuring comprehensive evaluation of luspatercepts effects.

Researchers are evaluating a cardiogenic shock protocol designed to improve communication and collaboration among hospitals to timely refer cardiogenic shock patients from spoke to hub centres in the Turin and Milan metropolitan areas. This observational study includes both a retrospective cohort from 2016 to 2019 and a prospective cohort starting in 2024. The purpose is to assess whether implementing this dedicated protocol reduces in-hospital or 30-day mortality in patients with acute myocardial infarction complicated by cardiogenic shock AMICS. Cardiogenic shock is a critical condition requiring rapid intervention and specialized care, and the study focuses on improving outcomes by optimizing patient transfer and treatment coordination. The study compares two groups one retrospective group of patients admitted before the protocol was implemented, and one prospective group admitted after the protocol adoption. Patients in the prospective cohort are managed under a standardized communication and referral protocol between spoke and hub centres, which include advanced cardiac interventions such as percutaneous mechanical circulatory support and prompt transfer to specialized teams. Hub centres have multidisciplinary shock teams, cardiac surgery backup, and 247 availability of cardiac care services. Spoke centres provide initial care and stabilization. The study involves 16 centres, with four hubs each receiving patients from three spoke centres. Participants will be monitored during their hospital stay and followed up to 30 days from admission. Data collected include clinical characteristics, treatments, timing of mechanical support device insertion, adverse events, and outcomes like mortality, stroke, bleeding, renal replacement therapy, vascular complications, and myocardial infarction. The study uses electronic health records and prospectively collected data, with no changes to standard care. The primary measure is 30-day mortality, and secondary outcomes include various clinical events and timing metrics related to treatment support. The study aims to provide insight into whether the hub-and-spoke protocol improves survival and quality of care for cardiogenic shock patients.