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Completed

NCT Number: NCT02063763

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

U.O.C di Ematologia P.O. "S.Giuseppe Moscati", Aversa, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of patients responding to TPO-mimetics

    Time frame: Six months.

    According to platelet count and presence or absence of hemorrhagic events.

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.

Acronym: ITP0614

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 14, 2014
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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