Assessing risks in patients without a spleen in France
Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients
This study looks at patients without a spleen to see what health risks they face and how to better manage their care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 12 sites (Angoulême and 11 other locations) |
| Trial ID | NCT04199403 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients who have undergone splenectomy, splenic artery embolization, or radiotherapy leading to asplenia. It aims to assess the complications associated with asplenia, including infectious diseases, cancer, and thromboembolic events. The study will implement new diagnostic tools to better understand splenic function and immunity over time in these patients. By following a national cohort of asplenic patients, the research seeks to identify risk factors and improve management strategies for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are asplenic due to splenectomy, splenic artery embolization, or radiotherapy.
Not a fit: Patients with genetic asplenia, such as those with sickle cell disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic tools and management strategies for patients without a spleen, potentially reducing their risk of serious complications.
How similar studies have performed: While there have been studies on splenectomized patients, this approach of assessing complications in a national cohort with a focus on new diagnostic tools is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 year-old * With asplenia due to splenectomy, splenic artery embolization or radiotherapy Exclusion Criteria: * Genetic asplenia including sick cell disease
Where this trial is running
Angoulême and 11 other locations
- C.H. d'Angoulême — Angoulême, France (Recruiting)
- C.H. Victor Dupouy — Argenteuil, France (Recruiting)
- C.H. de Béthune — Béthune, France (Recruiting)
- Hôpitaux de Chartres — Chartres, France (Recruiting)
- C.H.U. de Lille — Lille, France (Recruiting)
- C.H.U. de Montpellier — Montpellier, France (Recruiting)
- Hôtel-Dieu - CHU de Nantes — Nantes, France (Recruiting)
- C.H.U. de Poitiers — Poitiers, France (Recruiting)
- C.H.U. de Rouen — Rouen, France (Not_yet_recruiting)
- C.H.U. de Toulouse — Toulouse, France (Recruiting)
- C.H. de Tourcoing — Tourcoing, France (Recruiting)
- C.H. de Valenciennes — Valenciennes, France (Recruiting)
Study contacts
- Principal investigator: Mathieu PUYADE, MD — C.H.U. de Poitiers
- Study coordinator: Mathieu PUYADE, MD
- Email: mathieu.puyade@chu-poitiers.fr
- Phone: +33 5 49 44 32 76
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.