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Clinical Trials/NCT05806437
NCT05806437
Recruiting
Not Applicable

Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 site in 1 country142 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anemia, Iron Deficiency
Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Enrollment
142
Locations
1
Primary Endpoint
Reduction in transfusion patients
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Reduction in transfusion patients

Time Frame: 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)

Study Sites (1)

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