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

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

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Key information

Conditions

Anemia, Iron Deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro

Milan, Italy

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sideremil vita cp

Dietary Supplement

assunzione per 30 giorni dell'integratore

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic

Acronym: PBM(L4178)

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Apr 10, 2023
Registry last updated: Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed