Actively Recruiting

Age: 18Years +
All Genders
ID04199403

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

Led by Poitiers University Hospital · Updated on 2024-02-01

6000

Participants Needed

12

Research Sites

N/A

Total Duration

On this page

Sponsors

P

Poitiers University Hospital

Lead Sponsor

P

Pr Pierre BUFFET Institut National de la Transfusion Sanguine

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand the risks of complications in patients without a spleen (asplenic patients) in France. These patients may have lost spleen function due to surgery for trauma, cancer, autoimmune disease, or diagnostic reasons, or due to treatments like radiotherapy or splenic artery embolism. The study focuses on evaluating the risks of infections, cancer, and blood clot diseases in this group, as these complications are not well understood. The study observes patients with asplenia caused by splenectomy, splenic artery embolization, or radiotherapy. It plans a long-term follow-up to assess how splenic function and immunity change over time among different patient groups. New tools to assess residual spleen function will be used to improve patient management and better estimate the rates of infectious and non-infectious complications. Participants will be followed prospectively with evaluations over a period of three years. Researchers will monitor and assess complications and risk factors during this time. The main outcome measured is the assessment of complication risk factors related to asplenia. This observational study does not involve treatments but focuses on detailed follow-up of health outcomes and splenic function.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Have asplenia due to splenectomy, splenic artery embolization, or radiotherapy
Not Eligible

You will not qualify if you...

  • Genetic asplenia including sickle cell disease

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - Up to 3 years

Participants are observed over time to assess the incidence of infectious and non-infectious complications related to asplenia.

Trial Site Locations

Total: 12 locations

1

C.H. d'Angoulême

Angoulême, France, 16959

Actively Recruiting

2

C.H. Victor Dupouy

Argenteuil, France, 95100

Actively Recruiting

3

C.H. de Béthune

Béthune, France, 62660

Actively Recruiting

4

Hôpitaux de Chartres

Chartres, France, 28019

Actively Recruiting

5

C.H.U. de Lille

Lille, France, 59037

Actively Recruiting

6

C.H.U. de Montpellier

Montpellier, France, 34295

Actively Recruiting

7

Hôtel-Dieu - CHU de Nantes

Nantes, France, 44093

Actively Recruiting

8

C.H.U. de Poitiers

Poitiers, France, 86000

Actively Recruiting

9

C.H.U. de Rouen

Rouen, France, 76031

Not Yet Recruiting

10

C.H.U. de Toulouse

Toulouse, France, 31059

Actively Recruiting

11

C.H. de Tourcoing

Tourcoing, France, 59208

Actively Recruiting

12

C.H. de Valenciennes

Valenciennes, France, 59300

Actively Recruiting

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Research Team

M

Mathieu PUYADE, MD

C

Corinne Lorrain

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Long-term risks after splenectomy among 8,149 cancer-free American veterans: a cohort study with up to 27 years follow-up.

Sigurdur Y Kristinsson, Gloria Gridley, Robert N Hoover...

https://pubmed.ncbi.nlm.nih.gov/24056815

Splenic artery embolization versus splenectomy: Analysis for early in-hospital infectious complications and outcomes.

Alberto Aiolfi, Kenji Inaba, Aaron Strumwasser...

https://pubmed.ncbi.nlm.nih.gov/28459796