Recruitment

Recruitment Status
Completed
Estimated Enrollment
40

Inclusion Criterias

Indication for splenectomy due to refractory response to a previous therapy.
Have undergone splenectomy.
18 years of age or older.
...
Indication for splenectomy due to refractory response to a previous therapy.
Have undergone splenectomy.
18 years of age or older.
Have used eltrombopag or romiplostim to increase platelet count before splenectomy.
Persistent or chronic ITP in symtomatic phase.

Exclusion Criterias

No informed consent.
No informed consent.

Summary

Conditions
  • Adult Patients
  • Immune Primary Thrombocytopenia
  • Splenectomy
  • TPO-mimetics
Type
Observational
Design
  • Observational Model: Case-Only
  • Time Perspective: Retrospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Adult immune primary thrombocytopenia is an autoimmune malignancy characterized by platelet destruction and inadequate platelet production. Its incidence is of three cases per 100,000 people a year, with a prevalence in women in young and older adults. Splenectomy is, still today, the therapeutic ap...

Adult immune primary thrombocytopenia is an autoimmune malignancy characterized by platelet destruction and inadequate platelet production. Its incidence is of three cases per 100,000 people a year, with a prevalence in women in young and older adults. Splenectomy is, still today, the therapeutic approach that offers a bigger guarantee of a long term response (around 60+70%). Nevertheless, splenectomy may be accompanied by peri-operative complications in almost 10% of patients, which in rare cases may be fatal. These are normally hemorrhagic complications due to low platelet count. Thus, a previous therapy to increase platelets is advisable before any splenectomy. In patients who are refractory to corticosteroids and immunoglobulins or when its use is not indicated, splenectomy has a potential risk of more complications. Since the last few years, we count with TPO-mimetic drugs, specific for c-MPL receptor, able to stimulate platelet production, such as romiplostim and eltrombopag. Nowadays, TPO-mimetics are allowed in Italy when patients refuse splenectomy or when splenectomy is not contraindicated, but being ITP with a low platelet count (< 20-50.000/mmc) a potential contraindication to splenectomy due to hemorrhagic events, these drugs should be considered. Nevertheless, there are no data on therapeutic risks and safety of these agents when used for this indication. The aim of the present study is to verify, on an Italian national scale, the frequency of use, its impact and the safety profile.

Inclusion Criterias

Indication for splenectomy due to refractory response to a previous therapy.
Have undergone splenectomy.
18 years of age or older.
...
Indication for splenectomy due to refractory response to a previous therapy.
Have undergone splenectomy.
18 years of age or older.
Have used eltrombopag or romiplostim to increase platelet count before splenectomy.
Persistent or chronic ITP in symtomatic phase.

Exclusion Criterias

No informed consent.
No informed consent.

Locations

Novara
Terni
Aversa
Lecce
Milano
...
Novara
Terni
Aversa
Lecce
Milano
Roma
Verona
Monza
Milano
Firenze
Lido di Camaiore
Udine
Barletta
Milano

Tracking Information

NCT #
NCT02063763
Collaborators
Not Provided
Investigators
Study Chair: Francesco Zaja, Pr. Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia