Patient Blood Management in the Approach to Prosthetic Su... | NCT05806437

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

NCT05806437

Sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Status

Completed

Last Update Posted

Jun 29, 2026Actual

Enrollment

142Actual

Phase

Not Applicable

Conditions

Anemia, Iron Deficiency

Interventions

sideremil vita cp

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Jul 31, 2025Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Mar 28, 2023

First Submission Date that Met QC Criteria

Mar 28, 2023

First Posted Date

Apr 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2026

Last Update Posted Date

Jun 29, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

142Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Long assumption	Experimental	Assumpion of SideremilVita for 30 days	Dietary Supplement: sideremil vita cp
Standard assumption	Active Comparator	Assumpion of SideremilVita for 15 days	Dietary Supplement: sideremil vita cp

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sideremil vita cp	Dietary Supplement	assunzione per 30 giorni dell'integratore	Long assumption Standard assumption

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in transfusion patients	Evaluate the reduction of transfusions in anemic patients treated with SideremilVita, with comparison between a treatment for 30 days before the intervention (group B ), compared to patients assuming SideremilVita at 15 days before surgery (group A)	7 days post-surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 and/or % 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro		Milan			Italy

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided