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

January 30, 2024 updated by: Poitiers University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients >18 years with acquired asplenia due to splenectomy, artery embolization, or spleen radiotherapy

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Genetic asplenia including sick cell disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Single Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Collaborators

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

Investigators

  • Principal Investigator: Mathieu PUYADE, MD, C.H.U. de Poitiers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2020

Primary Completion (Estimated)

January 1, 2040

Study Completion (Estimated)

January 1, 2040

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 12, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SPLEEN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asplenia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe