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

Last updated: July 25, 2023
Sponsor: Istituto Ortopedico Galeazzi
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

sideremil vita cp

Clinical Study ID

NCT05806437
PBM(L4178)
  • Ages > 40
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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

Total Participants: 142
Treatment Group(s): 1
Primary Treatment: sideremil vita cp
Phase:
Study Start date:
June 01, 2023
Estimated Completion Date:
December 31, 2025

Study 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

Connect with a study center

  • IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro

    Milan,
    Italy

    Active - Recruiting

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