Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04199403

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

C.H. d'Angoulême, Angoulême, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Genetic asplenia including sick cell disease

Treatment and study plan

Primary outcomes

  1. Assessment of complication risk factors

    Time frame: 3 years

    Comparison between splenectomy and other type of asplenia for prevalence of infectious diseases, cancer, and thromboembolism disease

Study contacts

Contact information is provided by the study sponsor or research team.

Corinne Lorrain

CONTACT

[email protected]

+33 5 49 44 39 30

Mathieu PUYADE, MD

CONTACT

[email protected]

+33 5 49 44 32 76

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Collaborators

  • Dr Edouard TUAILLON Département Bactériologie-Virologie/INSERM U1058 CHU de Montpellier
  • Pr Pierre BUFFET Institut National de la Transfusion Sanguine

Registry information

Acronym: SPLEEN

Important dates

Study start
2020
Primary completion
2040
Study completion
2040
First posted
Dec 13, 2019
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.