AspleniaSPLEENNCT04199403
Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients
An observational study of Asplenia, run by Poitiers University Hospital at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asplenia
- How many people
- 6,000 participants
- Where
- 12 sitesFrance
- Study dates
- 9 Jan 2020to Jan 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients >18 years with acquired asplenia due to splenectomy, artery embolization, or spleen radiotherapy
Who may be able to join
- ≥18 year-old
- With asplenia due to splenectomy, splenic artery embolization or radiotherapy
Who cannot join
- Genetic asplenia including sick cell disease
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 10 recruiting
- Recruiting
C.H. d'Angoulême
Angoulême, 16959
Agnès RICHE, MD, agnes.riche@ch-angouleme.fr
- Recruiting
C.H. Victor Dupouy
Argenteuil, 95100
Damien CONTOU, MD, +33 1 34 23 11 73, damien.contou@ch-argenteuil.fr
- Withdrawn
C.H. de Béthune
Béthune, 62660
- Active, not recruiting
Hôpitaux de Chartres
Chartres, 28019
- Recruiting
C.H.U. de Lille
Lille, 59037
Fanny VUOTTO, MD, fanny.vuotto@chru-lille.fr
- Recruiting
C.H.U. de Montpellier
Montpellier, 34295
Corinne MERLE, MD, c-merle_de_boever@chu-montpellier.fr
- Recruiting
Hôtel-Dieu - CHU de Nantes
Nantes, 44093
Maeva LEFEBVRE, MD, maeva.lefebvre@chu-nantes.fr
- Recruiting
C.H.U. de Poitiers
Poitiers, 86000
Mathieu PUYADE, MD, +33 5 49 44 2 76, mathieu.puyade@chu-poitiers.fr
- Not yet recruiting
C.H.U. de Rouen
Rouen, 76031
Manuel ETIENNE, MD, manuel.etienne@chu-rouen.fr
- Recruiting
C.H.U. de Toulouse
Toulouse, 31059
Guillaume MARTIN-BLONDEL, MD, martin-blondel.g@chu-toulouse.fr
- Recruiting
C.H. de Tourcoing
Tourcoing, 59208
Nathalie VIGET, MD, nviget@ch-tourcoing.fr
- Recruiting
C.H. de Valenciennes
Valenciennes, 59300
Nicolas ETTAHAR, MD, ettahar-n@ch-valenciennes.fr
About this study
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.
Read the 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.
- Conditions
- Asplenia
- Keywords
- spleen, asplenic patients, splenectomy, asplenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of complication risk factors
Comparison between splenectomy and other type of asplenia for prevalence of infectious diseases, cancer, and thromboembolism disease
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start9 Jan 2020
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AspleniaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pr Pierre BUFFET Institut National de la Transfusion Sanguine, Dr Edouard TUAILLON Département Bactériologie-Virologie/INSERM U1058 CHU de Montpellier
- Responsible party
- Sponsor
- Investigators
- Mathieu PUYADE, MD, Principal investigator, C.H.U. de Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199403
- Sponsor's protocol ID
- SPLEEN
- Acronym
- SPLEEN
- Status last verified
- Jul 2026
- First submitted
- 12 Dec 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24056815Mebius RE, Kraal G. Structure and function of the spleen. Nat Rev Immunol. 2005 Aug;5(8):606-16. doi: 10.1038/nri1669.
PubMed 16056254Aiolfi 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.
PubMed 28459796
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Complication Risk Factors in a French National Cohort of Asplenic Patients
- ClinicalTrials.gov ID
- NCT04199403
- Acronym / sponsor ID
- SPLEEN / SPLEEN
- Conditions
- Asplenia
- Keywords
- spleen, asplenic patients, splenectomy, asplenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- Pr Pierre BUFFET Institut National de la Transfusion Sanguine, Dr Edouard TUAILLON Département Bactériologie-Virologie/INSERM U1058 CHU de Montpellier
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >18 years with acquired asplenia due to splenectomy, artery embolization, or spleen radiotherapy
Key inclusion criteria (2 listed)
- ≥18 year-old
- With asplenia due to splenectomy, splenic artery embolization or radiotherapy
Key exclusion criteria (1 listed)
- Genetic asplenia including sick cell disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Results publication: PubMed 24056815Kristinsson 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.
- Results publication: PubMed 16056254Mebius RE, Kraal G. Structure and function of the spleen. Nat Rev Immunol. 2005 Aug;5(8):606-16. doi: 10.1038/nri1669.
- Results publication: PubMed 28459796Aiolfi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mathieu PUYADE, MD principal investigator
C.H.U. de Poitiers
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asplenia, run by Poitiers University Hospital at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mathieu PUYADE, MD (+33 5 49 44 32 76, mathieu.puyade@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of complication risk factors (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04199403, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.