TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients. (ITP0614)
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|ClinicalTrials.gov Identifier: NCT02063763|
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : October 14, 2020
|Condition or disease|
|Adult Patients Immune Primary Thrombocytopenia Splenectomy TPO-mimetics|
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.
|Study Type :||Observational|
|Actual Enrollment :||31 participants|
|Official Title:||Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.|
|Actual Study Start Date :||May 14, 2014|
|Actual Primary Completion Date :||February 26, 2015|
|Actual Study Completion Date :||February 26, 2015|
- Number of patients responding to TPO-mimetics [ Time Frame: Six months. ]According to platelet count and presence or absence of hemorrhagic events.
- Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy. [ Time Frame: Six months. ]
- Frequency and ways of administration. [ Time Frame: Six months ]
- Number of hemorrhagic events. [ Time Frame: At thirty days from splenectomy. ]Number and seriousness of hemorrhagic, thrombotic and infectious events at 30 days from splenectomy.
- Frequency of toxicity. [ Time Frame: Six months ]NCI CTCAE v. 4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02063763
|U.O.C di Ematologia P.O. "S.Giuseppe Moscati"|
|UOC Ematologia Ospedale " Mons. Dimiccoli"|
|Policlinico di Careggi|
|ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE|
|Unità Operativa Complessa) - Medicina Generale - Sezione di Ematologia - Ospedale Versilia USL 12 Toscana|
|Lido di Camaiore, Italy|
|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano|
|Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano|
|Unità Trapianto di Midollo Ist. Nazionale Tumori|
|Azienda Ospedaliera "S.Gerardo"|
|S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro|
|Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia|
|A.O. Santa Maria - Terni S.C Oncoematologia|
|Clinica Ematologica - Policlinico Universitario|
|Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi|
|Study Chair:||Francesco Zaja, Pr.||Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia|