Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients

Asplenia Clinical Trial

— SPLEEN  

Official title:

Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199403
• Other study ID #: SPLEEN
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Asplenia

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