Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients
NCT ID: NCT04199403
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
6000 participants
OBSERVATIONAL
2020-01-09
2040-01-31
Brief Summary
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Detailed Description
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Three different risks are known for asplenic patients: infectious, neoplastic, and thromboembolic. Prevalence rate of infectious complications in splenectomized patients was 3.2% with a mortality rate of 1.4%. A US cohort study including 8149 splenectomized veterans have shown that the risk of cancer was increased, so did the risk of thromboembolic disease, on a 27-year period of follow-up. Pathophysiology of these risks are not well known.
There are very few tools to assess splenic function: Howell-Jolly bodies in red blood cells, scintigraphy. These tools lack sensitivity and are not correlated with complications in asplenic patients.
To better understand how splenic function and how immunity evolves during time in asplenic patients, a longitudinal follow-up could be useful. There may be some differences between splenectomized patients, those who benefited from splenic artery embolization, and those who received radiotherapy. Infectious risk may be different between these three groups. Implementing new tools assessing residual splenic function could improve management of these patients. A prospective follow-up aims at accurately estimate the incidence rate of infectious and non-infectious complications in this population.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single Group
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* With asplenia due to splenectomy, splenic artery embolization or radiotherapy
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pr Pierre BUFFET Institut National de la Transfusion Sanguine
UNKNOWN
Dr Edouard TUAILLON Département Bactériologie-Virologie/INSERM U1058 CHU de Montpellier
UNKNOWN
Poitiers University Hospital
OTHER
Responsible Party
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Principal Investigators
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Mathieu PUYADE, MD
Role: PRINCIPAL_INVESTIGATOR
C.H.U. de Poitiers
Locations
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C.H. d'Angoulême
Angoulême, , France
C.H. Victor Dupouy
Argenteuil, , France
C.H. de Béthune
Béthune, , France
Hôpitaux de Chartres
Chartres, , France
C.H.U. de Lille
Lille, , France
C.H.U. de Montpellier
Montpellier, , France
Hôtel-Dieu - CHU de Nantes
Nantes, , France
C.H.U. de Poitiers
Poitiers, , France
C.H.U. de Rouen
Rouen, , France
C.H.U. de Toulouse
Toulouse, , France
C.H. de Tourcoing
Tourcoing, , France
C.H. de Valenciennes
Valenciennes, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Kristinsson SY, Gridley G, Hoover RN, Check D, Landgren O. Long-term risks after splenectomy among 8,149 cancer-free American veterans: a cohort study with up to 27 years follow-up. Haematologica. 2014 Feb;99(2):392-8. doi: 10.3324/haematol.2013.092460. Epub 2013 Sep 20.
Mebius RE, Kraal G. Structure and function of the spleen. Nat Rev Immunol. 2005 Aug;5(8):606-16. doi: 10.1038/nri1669.
Aiolfi A, Inaba K, Strumwasser A, Matsushima K, Grabo D, Benjamin E, Lam L, Demetriades D. Splenic artery embolization versus splenectomy: Analysis for early in-hospital infectious complications and outcomes. J Trauma Acute Care Surg. 2017 Sep;83(3):356-360. doi: 10.1097/TA.0000000000001550.
Other Identifiers
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SPLEEN
Identifier Type: -
Identifier Source: org_study_id
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