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OUR MAIN PROJECTS

The Hematology Project Foundation has recently enlarged at a European level the scope of its activity beyond the ongoing national initiatives.
These latter include – among the most relevant:

  • Italian registry of patients with active ITP. 
    The objective of the study is to produce a dynamic picture of the adult ITP natural history and management in Italy. To this purpose, a nation-wide ITP registry representing the nation-wide best practices is collecting retrospective and prospective data on adult ITP patients requiring active treatment. PRIMARY OBJECTIVE: to investigate safety and efficacy outcomes of patients in active ITP, according to the different treatments and line of treatments. SECONDARY OBJECTIVES BASED ON PROSPECTIVE INVESTIGATION:
    1. Reason and type of any first and subsequent lines of treatment
    2. Estimation of the time spent in active treatment during the entire period of study (PoS) by each line of treatment
    3. Estimation of the time spent in the outcome categories: Complete Response (CR), Response (R), No Response (NR), No treatment (NT) and Toxicity (Tox)
    4. Incidence of particular side effects of the treatment and co-morbidities, including severe infections, thromboembolic events, liver or renal biochemical laboratory abnormalities, hypertension or diabetes requiring treatment, cataracts, any malignancies, mental deterioration and dementia, avascular osteonecrosis, other events leading to the discontinuation of a specific treatment
    5. Outcome of women’s specific issues including menorrhagia and pregnancy and their management
    6. Patient’s reported outcomes including QoL and Fatigue
    7 (???). Estimation of direct costs and healthcare resource (in a subset of centers).
    8. Estimation of Overall Survival
    9. Prevalence of splenectomy at enrolment and splenectomy rate during follow-up
    10. Assessment of bleeding using the standardized bleeding assessment tool SMOG
    11. Cross-sectional distribution of platelet counts at enrolment and at each follow-up visit, by phase of disease and by type of treatment (pre, during and post). The registry is currently involving 21 recruiting centers in Italy.
  • European Research Consortium on Immune Trombocytopenia (ERCI):
    The Hematology Project Foundation acts as the Administrative Headquarters of ERCI, a consortium founded by 10 distinguished researchers in ITP belonging to 6 European countries with the aim to provide a platform for future studies on Immune Thrombocytopenia and allied disorders; to encourage collaboration among interested parties and stakeholders, public or private; to identify unmet clinical needs in ITP and allied disorders; to promote standardization of terms and Management guidelines and Publications; and to apply for funding from EU or other national or international funding bodies or from other interested parties, commercial or not. All this, in order to improve awareness, knowledge, education in ITP and to improve the care of patients with ITP (www.ercigroup.org). The Scientific Director of HPF is a founding member of ERCI and acts as one of the two co-chairs of ERCI.

  • A national retrospective and prospective observational investigation on the incidence and course of COVID-19 in patients with prior, ongoing or de novo ITP:
    The study is a retrospective and prospective observational investigation conducted in Italian centers specialized in the management of ITP. The study is sponsored by GIMEMA Onlus Foundation (Roma) with the scientific collaboration of the Hematology Project Foundation (Vicenza) on patients with ITP and COVID19, treated at home or hospitalized. The project will evaluate, during a 2-years study period, both the cumulative incidence COVID19 occurring in patients with prior or ongoing ITP (COVID-19 in ITP) and the cumulative incidence of de novo ITP manifesting during COVID-19 (ITP in COVID-19). Furthermore, based on data on mortality and morbidity and their association with pre-selected co-variates, the clinical course of patients in both groups will be described. PRIMARY OBJECTIVE The primary objectives of the study are:
    • Evaluate the cumulative incidence of patients with known/ongoing ITP becoming infected by SARSCoV-2 (COVID-19 in ITP) from 1st January 2020 to 1st January 2022
    • Evaluate the cumulative incidence of COVID-19 patients developing de novo ITP (ITP in COVID19) from 1st January 2020 to 1st January 2022 SECONDARY OBJECTIVES The secondary objectives of the study are:
    • Describe the clinical outcome of ITP patients becoming infected by SARS-CoV-2
    • Describe the clinical outcome of COVID-19 patients developing ITP
    • Describe the impact (through a questionnaire-based survey) of COVID-19 pandemic on the current management of ITP, using data collected through a multi-domain survey on changes adopted (if any) because of the pandemic situation.
  • EHA Guidelines on Mild/Moderate Bleeding Disorders :
    Hematology Project Foundation (HPF) with its Scientific Director Prof. Francesco Rodeghiero is coordinating a project of the European Hematology Association for the development of consensus and evidence-based guidelines on inherited mild/moderate bleeding disorders. Noteworthy, practical recommendations for the management of these disorders are still lacking due to the current state of fragmented knowledge of pathophysiology and lack of a systematic diagnostic approach. A first paper with the methodology for the guidelines has already been published in the EHA Journal HemaSphere (Rodeghiero F et al, Fundamentals for a Systematic Approach to Mild and Moderate Inherited Bleeding Disorders: An EHA Consensus Report. HemaSphere. 3(5):e286, October 2019). Other 4 disease-specific guidelines are being developed on:
    1) Non-type 3 Von Willebrand disease;
    2) Coagulation and fibrinolytic system disorders;
    3) Platelet and vascular disorders;
    4) Bleeding of unknown cause..
  • A national survey on the use of TPO-RA in Italian ITP centers :
    88 haematologists from 79 Italian Haematology centers completed an independent on-line questionnaire based on a nation-wide survey designed to collect standardized data from Italian hematologists responsible of the management of ITP in adults to depict the common Italian practice in the approach to TPO-RAs prescription, taper and discontinuation and perceived risks or precautions in the administration of these agents.
  • Identification of critical areas requiring revisiting standardization of terminology and definitions in the management of ITP:
    through expert meetings, providing the participants with focused systematic literature search reviews preliminary to the production of consensus documents using a Delphi-like method.

 

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