Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients
SPLEEN
1 other identifier
observational
6,000
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
December 13, 2019
CompletedStudy Start
First participant enrolled
January 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2040
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2040
February 1, 2024
January 1, 2024
20 years
December 12, 2019
January 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of complication risk factors
Comparison between splenectomy and other type of asplenia for prevalence of infectious diseases, cancer, and thromboembolism disease
3 years
Study Arms (1)
Single Group
Eligibility Criteria
Patients \>18 years with acquired asplenia due to splenectomy, artery embolization, or spleen radiotherapy
You may qualify if:
- ≥18 year-old
- With asplenia due to splenectomy, splenic artery embolization or radiotherapy
You may not qualify if:
- Genetic asplenia including sick cell disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
C.H. d'Angoulême
Angoulême, 16959, France
C.H. Victor Dupouy
Argenteuil, 95100, France
C.H. de Béthune
Béthune, 62660, France
Hôpitaux de Chartres
Chartres, 28019, France
C.H.U. de Lille
Lille, 59037, France
C.H.U. de Montpellier
Montpellier, 34295, France
Hôtel-Dieu - CHU de Nantes
Nantes, 44093, France
C.H.U. de Poitiers
Poitiers, 86000, France
C.H.U. de Rouen
Rouen, 76031, France
C.H.U. de Toulouse
Toulouse, 31059, France
C.H. de Tourcoing
Tourcoing, 59208, France
C.H. de Valenciennes
Valenciennes, 59300, France
Related Publications (3)
Kristinsson SY, Gridley G, Hoover RN, Check D, Landgren O. Long-term risks after splenectomy among 8,149 cancer-free American veterans: a cohort study with up to 27 years follow-up. Haematologica. 2014 Feb;99(2):392-8. doi: 10.3324/haematol.2013.092460. Epub 2013 Sep 20.
PMID: 24056815RESULTMebius RE, Kraal G. Structure and function of the spleen. Nat Rev Immunol. 2005 Aug;5(8):606-16. doi: 10.1038/nri1669.
PMID: 16056254RESULTAiolfi A, Inaba K, Strumwasser A, Matsushima K, Grabo D, Benjamin E, Lam L, Demetriades D. Splenic artery embolization versus splenectomy: Analysis for early in-hospital infectious complications and outcomes. J Trauma Acute Care Surg. 2017 Sep;83(3):356-360. doi: 10.1097/TA.0000000000001550.
PMID: 28459796RESULT
Biospecimen
Blood samples
Study Officials
- PRINCIPAL INVESTIGATOR
Mathieu PUYADE, MD
C.H.U. de Poitiers
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2019
First Posted
December 13, 2019
Study Start
January 9, 2020
Primary Completion (Estimated)
January 1, 2040
Study Completion (Estimated)
January 1, 2040
Last Updated
February 1, 2024
Record last verified: 2024-01