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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Anemia, Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Long assumption

Assumpion of SideremilVita for 30 days

Group Type EXPERIMENTAL

sideremil vita cp

Intervention Type DIETARY_SUPPLEMENT

assunzione per 30 giorni dell'integratore

Standard assumption

Assumpion of SideremilVita for 15 days

Group Type ACTIVE_COMPARATOR

sideremil vita cp

Intervention Type DIETARY_SUPPLEMENT

assunzione per 30 giorni dell'integratore

Interventions

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sideremil vita cp

assunzione per 30 giorni dell'integratore

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No