TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients.
Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.
Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
|Source||Gruppo Italiano Malattie EMatologiche dell'Adulto|
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.
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.
|Overall Status||Unknown status|
|Start Date||May 2014|
|Completion Date||October 2018|
|Primary Completion Date||October 2018|
Sampling Method: Non-Probability Sample
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.
- 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.
- No informed consent.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Last Name: Enrico Crea
Email: [email protected]
|Has Expanded Access||No|
|Study Design Info||
Observational Model: Case-Only
Time Perspective: Retrospective