DiagnosticCARENFER-PBMNCT04800042
Study of the Prevalence of Iron Deficiency in Patients With Scheduled Major Surgery (CARENFER PBM)
A study testing Diagnostic test in people with Diagnostic, run by VIFORFRANCE.
Trial summary
Many patients who are candidates for scheduled major surgery have a pre-operative iron deficiency which is poorly diagnosed. The management of per-operative iron deficiency is a part of the concept of the "Patient Blood Management", which is a concept recommended by health regulatory agencies in many countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic
- What is being tested?
- Diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,700 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2021to 30 Sep 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, over 18 years of age
- Patient with scheduled major surgery
- Patient with signed consent
Who cannot join
- Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding woman
About this study
Many patients who are candidates for scheduled major surgery have a pre-operative iron deficiency which is poorly diagnosed. The management of per-operative iron deficiency is a part of the concept of the "Patient Blood Management", which is a concept recommended by health regulatory agencies in many countries. The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients undergoing a scheduled major surgery, applying the French recommendations (determination of ferritinemia and Transferrin Saturation Factor).
- Conditions
- Diagnostic
- Being tested
- Diagnostic test
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testDiagnostic test
Blood iron status : ferritin and transferrin saturation factor
| Study group | Role | What they receive |
|---|---|---|
| Patients with scheduled major surgery | Other | Patients with scheduled major surgery Receives: Diagnostic Test: Diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood iron status
Ferritin
Measured: Preoperative
Complete blood iron status
Transferrin Saturation Factor
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start15 Mar 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiagnosticStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VIFORFRANCE
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800042
- Sponsor's protocol ID
- CARENFER-PBM
- Acronym
- CARENFER-PBM
- Status last verified
- Mar 2021
- First submitted
- 9 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capdevila X, Lasocki S, Duchalais A, Rigal JC, Mertl P, Ghewy P, Farizon F, Lanz T, Buckert A, Belarbia S, Trochu JN, Cacoub P. Perioperative Iron Deficiency in Patients Scheduled for Major Elective Surgeries: A French Prospective Multicenter Cross-Sectional Study. Anesth Analg. 2023 Aug 1;137(2):322-331. doi: 10.1213/ANE.0000000000006445. Epub 2023 Mar 7.
PubMed 36881542
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Iron Deficiency in Patients With Scheduled Major Surgery (CARENFER PBM)
- ClinicalTrials.gov ID
- NCT04800042
- Acronym / sponsor ID
- CARENFER-PBM / CARENFER-PBM
- Conditions
- Diagnostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,700 participants (estimated)
- Lead sponsor
- VIFORFRANCEIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 16 Mar 2021 (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.
Many patients who are candidates for scheduled major surgery have a pre-operative iron deficiency which is poorly diagnosed. The management of per-operative iron deficiency is a part of the concept of the "Patient Blood Management", which is a concept recommended by health regulatory agencies in many countries. The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients undergoing a scheduled major surgery, applying the French recommendations (determination of ferritinemia and Transferrin Saturation Factor).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with scheduled major surgery | Other | Diagnostic Test: Diagnostic testPatients with scheduled major surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient, male or female, over 18 years of age
- Patient with scheduled major surgery
- Patient with signed consent
Key exclusion criteria (2 listed)
- Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant or breastfeeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic testBlood iron status : ferritin and transferrin saturation factor | Diagnostic test | Patients with scheduled major surgery |
Primary outcome
Blood iron status
Time frame: Preoperative
Ferritin
Complete blood iron status
Time frame: Preoperative
Transferrin Saturation Factor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Derived from this study: PubMed 36881542Capdevila X, Lasocki S, Duchalais A, Rigal JC, Mertl P, Ghewy P, Farizon F, Lanz T, Buckert A, Belarbia S, Trochu JN, Cacoub P. Perioperative Iron Deficiency in Patients Scheduled for Major Elective Surgeries: A French Prospective Multicenter Cross-Sectional Study. Anesth Analg. 2023 Aug 1;137(2):322-331. doi: 10.1213/ANE.0000000000006445. Epub 2023 Mar 7.
- Individual participant dataSharing planned: No
Related trials for Diagnostic
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test in people with Diagnostic, run by VIFORFRANCE.
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 2 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 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood iron status (time frame: Preoperative). The study lists 2 primary outcomes in all. 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 NCT04800042, which also lists 1 linked publication.
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 Mar 2021.