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NCT05806437 Clinical Trial

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

Anemia, Iron Deficiency Clinical Trial

— PBM(L4178)  

Official title:
Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05806437
Other study ID # PBM(L4178)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date December 31, 2025

Study information
Verified date March 2023
Source Istituto Ortopedico Galeazzi
Contact Elena Cittera
Phone 0283502224
Email elena.cittera@grupposandonato.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, and the national guideline on PBM (Patient blood management) also underlines this Hypothesis and relevance

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

Recruitment information / eligibility
Status Recruiting
Enrollment 142
Est. completion date December 31, 2025
Est. primary completion date July 31, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 - % 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• sideremil vita cp
assunzione per 30 giorni dell'integratore

Locations
Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro Milan

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in transfusion patients Evaluate the reduction of transfusions in anemic patients treated with SideremilVita for 30 days before the intervention (group B experimental), compared to patients assuming SideremilVita at 15 days before surgery (control group A) 7 days post-surgery
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