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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02063763

Acronym

ITP0614

Enrollment

Registered

2014-02-14

Start date

2014-05-14

Completion date

2015-02-26

Last updated

2020-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Adult patients, Immune primary thrombocytopenia, Splenectomy, TPO-mimetics, Eltrombopag, Romiplostim

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.	At thirty days from splenectomy.	Number and seriousness of hemorrhagic, thrombotic and infectious events at 30 days from splenectomy.
Frequency of toxicity.	Six months	NCI CTCAE v. 4.0

Countries

Italy

Outcome results