Splenectomy; StatusNCT05184647
Total Splenectomy vs Partial Splenectomy in Non-malignant Hemoglobinopathies : Study Comparing the Effectiveness
An observational study of Splenectomy; Status, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Partial splenectomy or total splenectomy are the two surgical treatment of non-malignant hemoglobinoptahie. The aim of this treatment is to decrease transfusion. The main risk is infectious in total splenectomy, that's why partial splenectomy was suggest. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Splenectomy; Status
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jan 2022to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children under 18 years olds with partial or total splenectomy for non malignant hemoglobinopathies
Who may be able to join
- Children between 0- 18 years olds
- Total or partial splenectomy
- Non malignant hémoglobinopathies
Who cannot join
- Total or partial splenectomy outside of non malignant hemoglobinopathies
Trial locations and contacts
1 site in 1 country.
France1 site
University hospital of Montpellier
Montpellier, 34295
nicolas KALFA, MD, 334 67 33 87 84, n-kalfa@chu-montpellier.fr
Benoit Tessier, benoitessier@gmail.com
About this study
Partial splenectomy or total splenectomy are the two surgical treatment of non-malignant hemoglobinoptahie. The aim of this treatment is to decrease transfusion. The main risk is infectious in total splenectomy, that's why partial splenectomy was suggest. But the efficiency of partial splenectomy decrease over time and a totalisation could be mandatory.
- Conditions
- Splenectomy; Status
- Keywords
- Pediatrics, Non-malignant hemoglobinopathies, Comprative effectivness, Partial Splenectomy, Total Splenectomy
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 |
|---|---|---|
| Children under 18 years olds with total splenectomy for non Malignant hemoglobinopathie | Children under 18 years olds with total splenectomy for non Malignant hemoglobinopathie | |
| Children under 18 years olds with partial splenectomy for non Malignant hemoglobinopathie | Children under 18 years olds with partial splenectomy for non Malignant hemoglobinopathie |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared the effectiveness with the number of transfusion
Compared the effectiveness with the number of transfusion after the surgery between total and partial Febrile urinary tract infection was defined as a positive urine examination with a single bacteria with more than 10.5 cfu/mL and more than 10.4 leukocytes/ml associated with fever above 38.5°C and C-reactive protein (CRP) above 50 mg/
Measured: Day 1
Secondary outcomes (2)
Number of infectious event in total and partial splenectomy
Number of infectious event in total and partial splenectomy
Measured: Day 1
number of totalisation in partial
number of totalisation in partial
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start16 Jan 2022 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenectomy; StatusStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas KALFA, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05184647
- Sponsor's protocol ID
- RECHMPL21_0712
- Status last verified
- Dec 2021
- First submitted
- 22 Dec 2021
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Splenectomy vs Partial Splenectomy in Non-malignant Hemoglobinopathies : Study Comparing the Effectiveness
- ClinicalTrials.gov ID
- NCT05184647
- Acronym / sponsor ID
- RECHMPL21_0712
- Conditions
- Splenectomy; Status
- Keywords
- Pediatrics, Non-malignant hemoglobinopathies, Comprative effectivness, Partial Splenectomy, Total Splenectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Jan 2022 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
Partial splenectomy or total splenectomy are the two surgical treatment of non-malignant hemoglobinoptahie. The aim of this treatment is to decrease transfusion. The main risk is infectious in total splenectomy, that's why partial splenectomy was suggest. But the efficiency of partial splenectomy decrease over time and a totalisation could be mandatory.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children under 18 years olds with total splenectomy for non Malignant hemoglobinopathie | – | –Children under 18 years olds with total splenectomy for non Malignant hemoglobinopathie |
| Children under 18 years olds with partial splenectomy for non Malignant hemoglobinopathie | – | –Children under 18 years olds with partial splenectomy for non Malignant hemoglobinopathie |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children under 18 years olds with partial or total splenectomy for non malignant hemoglobinopathies
Key inclusion criteria (3 listed)
- Children between 0- 18 years olds
- Total or partial splenectomy
- Non malignant hémoglobinopathies
Key exclusion criteria (1 listed)
- Total or partial splenectomy outside of non malignant hemoglobinopathies
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
Compared the effectiveness with the number of transfusion
Time frame: Day 1
Compared the effectiveness with the number of transfusion after the surgery between total and partial Febrile urinary tract infection was defined as a positive urine examination with a single bacteria with more than 10.5 cfu/mL and more than 10.4 leukocytes/ml associated with fever above 38.5°C and C-reactive protein (CRP) above 50 mg/
2 secondary outcomes
Number of infectious event in total and partial splenectomy
Time frame: Day 1
number of totalisation in partial
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided. NC
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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. This study is not recruiting at the moment.
Nicolas KALFA study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Splenectomy; Status, run by University Hospital, Montpellier at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas KALFA, MD (00334 67 33 87 84, n-kalfa@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compared the effectiveness with the number of transfusion (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2022.