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

July 25, 2023 updated by: Istituto Ortopedico Galeazzi

Patient Blood Management in the Approach to Prosthetic Surgery in Orthopedic

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro
        • Contact:
        • Principal Investigator:
          • Giorgio Oriani

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long assumption
Assumpion of SideremilVita for 30 days
Dietary supplement: sideremil vita cp
assunzione per 30 giorni dell'integratore
Active Comparator: Standard assumption
Assumpion of SideremilVita for 15 days
Dietary supplement: sideremil vita cp
assunzione per 30 giorni dell'integratore

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
7 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBM(L4178)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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