Anemia, Iron DeficiencyPBM(L4178)NCT05806437
Patient Blood Management in the Approach to Prosthetic Surgery [PBM(L4178)]
A study testing sideremil vita cp in people with Anemia, Iron Deficiency, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
We have been well guided in the "Good use of blood" during major surgery for many years, reaching a percentage of 4% of patients transfused after elective prosthetic operations. Valid patient blood management must provide for the possibility of limiting/zeroing the transfusion risk dependent on preoperative anemia… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- sideremil vita cp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2023to 31 Dec 2025
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for prosthetic surgery
- Patients of both sexes over 40 years of age
- Hemoglobin values <12 g% for females and 13 g% for males and/or % transferrin saturation < 10%
- Willingness and ability to provide informed consent.
Who cannot join
- Patients with Mediterranean anemia
- Patients with coagulation disorders
- Patients who do not sign the consent form
- Pregnant or breastfeeding women (self-declaration)
- Minor aged
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic
We have been well guided in the "Good use of blood" during major surgery for many years, reaching a percentage of 4% of patients transfused after elective prosthetic operations. Valid patient blood management must provide for the possibility of limiting/zeroing the transfusion risk dependent on preoperative anemia, and the national guideline on PBM (Patient blood management) also underlines this Hypothesis and relevance
Read the detailed description
We want to analyse patients from a diagnostic point of view (occult blood, diverticulitis, gastrorrhagia) and from the point of view of laboratory parameters (blood count, serum iron, transferrinemia, ferritinemia, transferrin saturation) in ordr to be able to suggest the best approach in preparation to the intervention.
We want to evaluate the effectiveness of this approach, considering the proposed treatments (ferric carboxymaltose, chelated iron, folic acid, sideremil vita) and the transfusion result (or not) obtained
- Conditions
- Anemia, Iron Deficiency
- Being tested
- sideremil vita cp
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sideremil vita cpDietary supplement
assunzione per 30 giorni dell'integratore
| Study group | Role | What they receive |
|---|---|---|
| Long assumption | Experimental | Assumpion of SideremilVita for 30 days Receives: Dietary Supplement: sideremil vita cp |
| Standard assumption | Active comparator | Assumpion of SideremilVita for 15 days Receives: Dietary Supplement: sideremil vita cp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in transfusion patients
Evaluate the reduction of transfusions in anemic patients treated with SideremilVita, with comparison between a treatment for 30 days before the intervention (group B ), compared to patients assuming SideremilVita at 15 days before surgery (group A)
Measured: 7 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806437
- Sponsor's protocol ID
- PBM(L4178)
- Acronym
- PBM(L4178)
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic
- ClinicalTrials.gov ID
- NCT05806437
- Acronym / sponsor ID
- PBM(L4178) / PBM(L4178)
- Conditions
- Anemia, Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Apr 2023 (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.
We have been well guided in the "Good use of blood" during major surgery for many years, reaching a percentage of 4% of patients transfused after elective prosthetic operations. Valid patient blood management must provide for the possibility of limiting/zeroing the transfusion risk dependent on preoperative anemia, and the national guideline on PBM (Patient blood management) also underlines this Hypothesis and relevance
Detailed description
We want to analyse patients from a diagnostic point of view (occult blood, diverticulitis, gastrorrhagia) and from the point of view of laboratory parameters (blood count, serum iron, transferrinemia, ferritinemia, transferrin saturation) in ordr to be able to suggest the best approach in preparation to the intervention.
We want to evaluate the effectiveness of this approach, considering the proposed treatments (ferric carboxymaltose, chelated iron, folic acid, sideremil vita) and the transfusion result (or not) obtained
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long assumption | Experimental | Dietary Supplement: sideremil vita cpAssumpion of SideremilVita for 30 days |
| Standard assumption | Active comparator | Dietary Supplement: sideremil vita cpAssumpion of SideremilVita for 15 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Candidates for prosthetic surgery
- Patients of both sexes over 40 years of age
- Hemoglobin values <12 g% for females and 13 g% for males and/or % transferrin saturation < 10%
- Willingness and ability to provide informed consent.
Key exclusion criteria (5 listed)
- Patients with Mediterranean anemia
- Patients with coagulation disorders
- Patients who do not sign the consent form
- Pregnant or breastfeeding women (self-declaration)
- Minor aged
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 |
|---|---|---|
| sideremil vita cpassunzione per 30 giorni dell'integratore | Dietary supplement | Long assumption, Standard assumption |
Primary outcome
Reduction in transfusion patients
Time frame: 7 days post-surgery
Evaluate the reduction of transfusions in anemic patients treated with SideremilVita, with comparison between a treatment for 30 days before the intervention (group B ), compared to patients assuming SideremilVita at 15 days before surgery (group A)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sideremil vita cp in people with Anemia, Iron Deficiency, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jun 2026. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in transfusion patients (time frame: 7 days post-surgery). 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 29 Jun 2026.