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

Last updated: January 30, 2024
Sponsor: Poitiers University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04199403
SPLEEN
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 year-old
  • With asplenia due to splenectomy, splenic artery embolization or radiotherapy

Exclusion

Exclusion Criteria:

  • Genetic asplenia including sick cell disease

Study Design

Total Participants: 6000
Study Start date:
January 09, 2020
Estimated Completion Date:
January 31, 2040

Study 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.

Connect with a study center

  • C.H. d'Angoulême

    Angoulême, 16959
    France

    Active - Recruiting

  • C.H. Victor Dupouy

    Argenteuil, 95100
    France

    Active - Recruiting

  • C.H. de Béthune

    Béthune, 62660
    France

    Active - Recruiting

  • Hôpitaux de Chartres

    Chartres, 28019
    France

    Active - Recruiting

  • C.H.U. de Lille

    Lille, 59037
    France

    Active - Recruiting

  • C.H.U. de Montpellier

    Montpellier, 34295
    France

    Active - Recruiting

  • Hôtel-Dieu - CHU de Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • C.H.U. de Poitiers

    Poitiers, 86000
    France

    Active - Recruiting

  • C.H.U. de Rouen

    Rouen, 76031
    France

    Site Not Available

  • C.H.U. de Toulouse

    Toulouse, 31059
    France

    Active - Recruiting

  • C.H. de Tourcoing

    Tourcoing, 59208
    France

    Active - Recruiting

  • C.H. de Valenciennes

    Valenciennes, 59300
    France

    Active - Recruiting

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