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Patient Blood Management in the Approach to Prosthetic Surgery [PBM(L4178)]

Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05806437
Acronym
PBM(L4178)
Enrollment
142
Registered
2023-04-10
Start date
2023-06-01
Completion date
2025-12-31
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Iron Deficiency

Brief 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, 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

Interventions

DIETARY_SUPPLEMENTsideremil vita cp

assunzione per 30 giorni dell'integratore

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Patients with Mediterranean anemia * Patients with coagulation disorders * Patients who do not sign the consent form * Pregnant or breastfeeding women (self-declaration) * Minor aged

Design outcomes

Primary

MeasureTime frameDescription
Reduction in transfusion patients7 days post-surgeryEvaluate 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)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026