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

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

Status: Enrolling

Conditions: Anemia, Iron Deficiency

Treatments: Dietary Supplement: sideremil vita cp

Study type: Interventional

Funder types: Other

Identifiers

NCT05806437

PBM(L4178)

Details and patient eligibility

About

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

Full 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

Enrollment: 142 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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142 participants in 2 patient groups

Long assumption

Experimental group

Description:

Assumpion of SideremilVita for 30 days

Treatment:

Dietary Supplement: sideremil vita cp

Standard assumption

Active Comparator group

Description:

Assumpion of SideremilVita for 15 days

Treatment:

Dietary Supplement: sideremil vita cp