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
About this trial
This is an interventional supportive care trial for Anemia, Iron Deficiency
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
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
NCT ID
NCT05806437
First Posted
March 28, 2023
Last Updated
July 25, 2023
Sponsor
Istituto Ortopedico Galeazzi
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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