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

Not Applicable

Recruiting

• Conditions: Anemia, Iron Deficiency
• Interventions: Dietary Supplement: sideremil vita cp

• Registration Number: NCT05806437
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-04-10
• Study Start: 2023-06-01
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard assumption	sideremil vita cp	Assumpion of SideremilVita for 15 days
Long assumption	sideremil vita cp	Assumpion of SideremilVita for 30 days

Primary Outcome Measures

Name	Time	Method
Reduction in transfusion patients	7 days post-surgery	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)

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro; 🇮🇹 Milan, Italy