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

Primary Purpose

Anemia, Iron Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
sideremil vita cp
Sponsored by
Istituto Ortopedico Galeazzi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anemia, Iron Deficiency

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San SiroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Long assumption

Standard assumption

Arm Description

Assumpion of SideremilVita for 30 days

Assumpion of SideremilVita for 15 days

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
March 28, 2023
Last Updated
July 25, 2023
Sponsor
Istituto Ortopedico Galeazzi
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1. Study Identification

Unique Protocol Identification Number
NCT05806437
Brief Title
Patient Blood Management in the Approach to Prosthetic Surgery [PBM(L4178)]
Acronym
PBM(L4178)
Official Title
Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Iron Deficiency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long assumption
Arm Type
Experimental
Arm Description
Assumpion of SideremilVita for 30 days
Arm Title
Standard assumption
Arm Type
Active Comparator
Arm Description
Assumpion of SideremilVita for 15 days
Intervention Type
Dietary Supplement
Intervention Name(s)
sideremil vita cp
Intervention Description
assunzione per 30 giorni dell'integratore
Primary Outcome Measure Information:
Title
Reduction in transfusion patients
Description
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)
Time Frame
7 days post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Cittera
Phone
0283502224
Email
elena.cittera@grupposandonato.it
Facility Information:
Facility Name
IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Cittera
Phone
00390283502224
Email
elena.cittera@grupposandonato.it
First Name & Middle Initial & Last Name & Degree
Giorgio Oriani

12. IPD Sharing Statement

Learn more about this trial

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

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