TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients.

Study Overview
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Brief Summary
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This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and Romiplostim as bridge therapy for splenectomy in adult patients with primary immune thrombocytopenia.

Detailed Description
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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.

Official Title
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Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.

Conditions
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Adult Patients, Immune Primary Thrombocytopenia, Splenectomy, TPO-mimetics

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent or chronic ITP in symtomatic phase. 18 years of age or older. Indication for splenectomy due to refractory response to a previous therapy. Have used eltrombopag or romiplostim to increase platelet count before splenectomy. Have undergone splenectomy. Exclusion Criteria: No informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients responding to TPO-mimetics | According to platelet count and presence or absence of hemorrhagic events. | Six months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy. |  | Six months. | 
| Frequency and ways of administration. |  | Six months | 
| Number of hemorrhagic events. | Number and seriousness of hemorrhagic, thrombotic and infectious events at 30 days from splenectomy. | At thirty days from splenectomy. | 
| Frequency of toxicity. | NCI CTCAE v. 4.0 | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immune primary thrombocytopenia, Splenectomy, Adult patients, TPO-mimetics, Eltrombopag, Romiplostim