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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02063763
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : October 14, 2020
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.

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Study Type : Observational
Actual Enrollment : 31 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.
Actual Study Start Date : May 14, 2014
Actual Primary Completion Date : February 26, 2015
Actual Study Completion Date : February 26, 2015





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


Locations
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Italy
U.O.C di Ematologia P.O. "S.Giuseppe Moscati"
Aversa, Italy
UOC Ematologia Ospedale " Mons. Dimiccoli"
Barletta, Italy
Policlinico di Careggi
Firenze, Italy
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE
Lecce, Italy
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
Milano, Italy
Ospedale Niguarda " Ca Granda" - SC Ematologia Blocco SUD, Ponti Est, Scala E, 4° piano
Milano, Italy
Unità Trapianto di Midollo Ist. Nazionale Tumori
Milano, Italy
Azienda Ospedaliera "S.Gerardo"
Monza, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
Novara, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy
A.O. Santa Maria - Terni S.C Oncoematologia
Terni, Italy
Clinica Ematologica - Policlinico Universitario
Udine, Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, Italy
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Study Chair: Francesco Zaja, Pr. Clinica Ematologica, DISM, Azienda Ospedaliera Universitaria S. M. Misericordia
Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT02063763    
Other Study ID Numbers: ITP0614
First Posted: February 14, 2014    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
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:
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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