NCT05806437

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

2.2 years

First QC Date

March 28, 2023

Last Update Submit

June 24, 2026

Conditions

Anemia, Iron Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

sideremil vita cpDIETARY_SUPPLEMENT

assunzione per 30 giorni dell'integratore

Long assumptionStandard assumption

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with Mediterranean anemia
  • Patients with coagulation disorders
  • Patients who do not sign the consent form
  • Pregnant or breastfeeding women (self-declaration)
  • Minor aged

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi-Istituto Clinico San Siro

Milan, Italy

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

June 1, 2023

Primary Completion

July 31, 2025

Study Completion

December 31, 2025

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations

IT(1)