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" |
Casale M, Perrotta S. Splenectomy for hereditary spherocytosis: complete, partial or not at all? Expert Rev Hematol. 2011 Dec;4(6):627-35. doi: 10.1586/EHM.11.51. Review. — View Citation
Gill FM, Sleeper LA, Weiner SJ, Brown AK, Bellevue R, Grover R, Pegelow CH, Vichinsky E. Clinical events in the first decade in a cohort of infants with sickle cell disease. Cooperative Study of Sickle Cell Disease. Blood. 1995 Jul 15;86(2):776-83. Review. — View Citation
Hongeng S, Wilimas JA, Harris S, Day SW, Wang WC. Recurrent Streptococcus pneumoniae sepsis in children with sickle cell disease. J Pediatr. 1997 May;130(5):814-6. Erratum in: J Pediatr 1997 Aug;131(2):232. — View Citation
Hosea SW, Burch CG, Brown EJ, Berg RA, Frank MM. Impaired immune response of splenectomised patients to polyvalent pneumococcal vaccine. Lancet. 1981 Apr 11;1(8224):804-7. — View Citation
Jaïs X, Ioos V, Jardim C, Sitbon O, Parent F, Hamid A, Fadel E, Dartevelle P, Simonneau G, Humbert M. Splenectomy and chronic thromboembolic pulmonary hypertension. Thorax. 2005 Dec;60(12):1031-4. Epub 2005 Aug 5. — View Citation
Kruetzmann S, Rosado MM, Weber H, Germing U, Tournilhac O, Peter HH, Berner R, Peters A, Boehm T, Plebani A, Quinti I, Carsetti R. Human immunoglobulin M memory B cells controlling Streptococcus pneumoniae infections are generated in the spleen. J Exp Med. 2003 Apr 7;197(7):939-45. — View Citation
Lee A, Thomas P, Cupidore L, Serjeant B, Serjeant G. Improved survival in homozygous sickle cell disease: lessons from a cohort study. BMJ. 1995 Dec 16;311(7020):1600-2. — View Citation
Pearson HA, Spencer RP, Cornelius EA. Functional asplenia in sickle-cell anemia. N Engl J Med. 1969 Oct 23;281(17):923-6. — View Citation
Quinn CT, Rogers ZR, Buchanan GR. Survival of children with sickle cell disease. Blood. 2004 Jun 1;103(11):4023-7. Epub 2004 Feb 5. — View Citation
Sullivan JL, Ochs HD, Schiffman G, Hammerschlag MR, Miser J, Vichinsky E, Wedgwood RJ. Immune response after splenectomy. Lancet. 1978 Jan 28;1(8057):178-81. — View Citation
Taher AT, Musallam KM, Karimi M, El-Beshlawy A, Belhoul K, Daar S, Saned MS, El-Chafic AH, Fasulo MR, Cappellini MD. Overview on practices in thalassemia intermedia management aiming for lowering complication rates across a region of endemicity: the OPTIMAL CARE study. Blood. 2010 Mar 11;115(10):1886-92. doi: 10.1182/blood-2009-09-243154. Epub 2009 Dec 23. — View Citation
Waghorn DJ. Overwhelming infection in asplenic patients: current best practice preventive measures are not being followed. J Clin Pathol. 2001 Mar;54(3):214-8. — View Citation
Wright J, Thomas P, Serjeant GR. Septicemia caused by Salmonella infection: an overlooked complication of sickle cell disease. J Pediatr. 1997 Mar;130(3):394-9. — View Citation
* 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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