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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04199403
Other study ID # SPLEEN
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 9, 2020
Est. completion date January 2040

Study information

Verified date January 2024
Source Poitiers University Hospital
Contact Mathieu PUYADE, MD
Phone +33 5 49 44 32 76
Email mathieu.puyade@chu-poitiers.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Spleen could have been surgically removed for trauma, cancer, auto-immune disease, or to perform a diagnosis. Spleen could be non-functional due to radiotherapy or splenic artery embolism. These patients are at risks of infectious diseases due to encapsulated bacteria, cancer, and thromboembolism disease. The purpose of this study is to assess complications occurring in French patients without spleen and to implement new diagnostic tools for follow-up.


Description:

Asplenia can be congenital or acquired. Acquired asplenia can be due to diagnostic or therapeutic surgery, splenic artery embolization, or radiotherapy. Incidence of splenectomized patients was estimated between 10 and 15/100 000 persons in 2003. More recent data suggested a decrease in splenectomy due to increase of splenic artery embolization. From 212 to 2016, about 4000 splenectomy had still been performed. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6000
Est. completion date January 2040
Est. primary completion date January 2040
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - =18 year-old - With asplenia due to splenectomy, splenic artery embolization or radiotherapy Exclusion Criteria: - Genetic asplenia including sick cell disease

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France 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

Sponsors (3)

Lead Sponsor Collaborator
Poitiers University Hospital Dr Edouard TUAILLON Département Bactériologie-Virologie/INSERM U1058 CHU de Montpellier, Pr Pierre BUFFET Institut National de la Transfusion Sanguine

Country where clinical trial is conducted

France, 

References & Publications (3)

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):356-3 — View Citation

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. E — View Citation

Mebius RE, Kraal G. Structure and function of the spleen. Nat Rev Immunol. 2005 Aug;5(8):606-16. doi: 10.1038/nri1669. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of complication risk factors Comparison between splenectomy and other type of asplenia for prevalence of infectious diseases, cancer, and thromboembolism disease 3 years
See also
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Recruiting NCT02232191 - Immunologic Response to Pneumococcal Polysaccharide Vaccine in Splenic Injury Patients Phase 2