Functional Recovery Over the First Year After ICU Discharge
NCT04206306
Adult Patients, Intensive Care Unit
Taipei, Taiwan
View Trial DetailsNCT Number: NCT02063763
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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Notify Me18 year and older
All sexes
Observational
U.O.C di Ematologia P.O. "S.Giuseppe Moscati", Aversa, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Six months.
According to platelet count and presence or absence of hemorrhagic events.
Time frame: Six months.
Time frame: Six months
Time frame: At thirty days from splenectomy.
Number and seriousness of hemorrhagic, thrombotic and infectious events at 30 days from splenectomy.
Time frame: Six months
NCI CTCAE v. 4.0
Gruppo Italiano Malattie EMatologiche dell'Adulto
Other
Use of TPO-mimetics to Prepare for Splenectomy in Adult Patients With Primary Immune Thrombocytopenia. Brooklyn Observational Retrospective Study.
Acronym: ITP0614
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