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Trial record 36 of 42 for:    Recruiting Studies | ITP

TPO-mimetics Before Splenectomy in Adult Primary Immune Thrombocytopenia Patients. (ITP0614)

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ClinicalTrials.gov Identifier: NCT02063763
Recruitment Status : Recruiting
First Posted : February 14, 2014
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:
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.

Condition or disease
Adult Patients Immune Primary Thrombocytopenia Splenectomy TPO-mimetics

Detailed 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 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
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.
Study Start Date : May 2014
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018





Primary Outcome Measures :
  1. Number of patients responding to TPO-mimetics [ Time Frame: Six months. ]
    According to platelet count and presence or absence of hemorrhagic events.


Secondary Outcome Measures :
  1. Number of patients on TPO-mimetics eltrombopag and romiplostim as bridge therapy before splenectomy. [ Time Frame: Six months. ]
  2. Frequency and ways of administration. [ Time Frame: Six months ]
  3. 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.

  4. Frequency of toxicity. [ Time Frame: Six months ]
    NCI CTCAE v. 4.0



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ITP adult patients having undergone splenectomy after a bridge therapy with eltrombopag or romiplostim.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Enrico Crea e.crea@gimema.it

Locations
Italy
U.O.C di Ematologia P.O. "S.Giuseppe Moscati" Recruiting
Aversa, Italy
Contact: Giuseppe Caparrotti         
Principal Investigator: Giuseppe Caparrotti         
Sub-Investigator: Daniela Esposito         
UOC Ematologia Ospedale " Mons. Dimiccoli" Recruiting
Barletta, Italy
Contact: Giuseppe Tarantini         
Principal Investigator: Giuseppe Tarantini         
Sub-Investigator: Caterina Buquicchio         
Policlinico di Careggi Recruiting
Firenze, Italy
Contact: Alberto Bosi         
Principal Investigator: Alberto Bosi         
Sub-Investigator: Valentina Carrai         
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE Recruiting
Lecce, Italy
Contact: Nicola Di Renzo         
Principal Investigator: Nicola Di Renzo         
Sub-Investigator: Margherita Giannoccaro         
Unità Operativa Complessa) - Medicina Generale - Sezione di Ematologia - Ospedale Versilia USL 12 Toscana Recruiting
Lido di Camaiore, Italy
Contact: Paola Lambelet         
Principal Investigator: Paola Lambelet         
Sub-Investigator: Federico Simonetti         
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano Recruiting
Milano, Italy
Contact: Wilma Barcellini         
Principal Investigator: Wilma Barcellini         
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano Recruiting
Milano, Italy
Contact: Silvia Cantoni         
Principal Investigator: Silvia Cantoni         
Unità Trapianto di Midollo Ist. Nazionale Tumori Recruiting
Milano, Italy
Contact: Massimo Di Nicola         
Principal Investigator: Massimo Di Nicola         
Sub-Investigator: Michele Magni         
Azienda Ospedaliera "S.Gerardo" Recruiting
Monza, Italy
Contact: Monica Carpenedo         
Principal Investigator: Monica Carpenedo         
Sub-Investigator: Veronica Coccini         
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro Not yet recruiting
Novara, Italy
Contact: Gianluca Gaidano         
Principal Investigator: Gianluca Gaidano         
Sub-Investigator: Mariangela Greco         
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia Recruiting
Roma, Italy
Contact: Maria Gabriella Mazzucconi         
Principal Investigator: Maria Gabriella Mazzucconi         
A.O. Santa Maria - Terni S.C Oncoematologia Recruiting
Terni, Italy
Contact: Anna Maria Liberati         
Principal Investigator: Anna Maria Liberati         
Sub-Investigator: Angelo Genna         
Clinica Ematologica - Policlinico Universitario Recruiting
Udine, Italy
Contact: Francesco Zaja         
Principal Investigator: Francesco Zaja         
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi Recruiting
Verona, Italy
Contact: Dino Veneri         
Principal Investigator: Dino Veneri         
Sub-Investigator: Giovanni Pizzolo         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Study Chair: Francesco Zaja, Pr. Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia

Additional Information:
Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT02063763     History of Changes
Other Study ID Numbers: ITP0614
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Adult patients
Immune primary thrombocytopenia
Splenectomy
TPO-mimetics
Eltrombopag
Romiplostim

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms