Splenectomy; Status Clinical Trial
Official title:
Mortality and Morbidity in a Large Cohort of Asplenic Patients: a Nationwide Survey From the Italian Network on Asplenia
NCT number | NCT03571399 |
Other study ID # | Asplenia |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2016 |
Est. completion date | February 28, 2017 |
Verified date | May 2018 |
Source | Società Italiana Talassemie ed Emoglobinopatie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Spleen is involved in several functions, such as the production of protective antibodies, the removal of unwanted particulate matter from the blood (eg bacteria) and also the storing of blood cells, especially white cells and platelets. Asplenia is a status due to spleen absence or dysfunction, which results from several rare diseases. Congenital Asplenia is a condition with absent or dysfunctional spleen, associated with other congenital abnormalities; functional asplenia is a status with present but dysfunctional spleen, related to many rare diseases, such as sickle cell disease, thalassemia, essential thrombocythaemia, lymphoproliferative diseases and splenectomy is the surgical removal of the spleen in order to treat a huge number of rare hematological and oncological diseases. So, asplenia is the final result of a numerous variety of rare disorders, and it leads to a high risk of infections and thrombotic events with significant mortality and morbidity. Antibiotic prophylaxis and specific vaccinations are recommended in this high risk population but adherence was shown to be very poor. A national register was demonstrated to improve population outcomes and reduce health care costs and facilitate research and public health purposes in this target population. In Europe very little experience exists in comprehensive national program for management of asplenia, and only in a restricted part of England and in Ireland surveys of post-splenectomized patients have been performed. In Italy no common policy of patient care has yet been developed, and management of asplenia is mainly case or locally directed.
Status | Completed |
Enrollment | 1400 |
Est. completion date | February 28, 2017 |
Est. primary completion date | March 1, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Adult and pediatric patients affected by asplenia Exclusion Criteria: - Medical history including all relevant clinical data required by the protocol not available |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Società Italiana Talassemie ed Emoglobinopatie | University of Campania "Luigi Vanvitelli" |
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of the causes of mortality and morbidity | The infectious and the thrombotic complication developed by asplenic patients during the observation period will be assessed | 10 years |
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