Study of the Prevalence of Iron Deficiency in Patients With Scheduled Major Surgery (CARENFER PBM)

Not Applicable

• Conditions: Diagnostic
• Interventions: Diagnostic Test: Diagnostic test

• Registration Number: NCT04800042
• Lead Sponsor: VIFORFRANCE

Brief Summary

Many patients who are candidates for scheduled major surgery have a pre-operative iron deficiency which is poorly diagnosed. The management of per-operative iron deficiency is a part of the concept of the "Patient Blood Management", which is a concept recommended by health regulatory agencies in many countries. The objective of this study is to obtain updated data on the prevalence of iron deficiency in France in patients undergoing a scheduled major surgery, applying the French recommendations (determination of ferritinemia and Transferrin Saturation Factor).

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-09
• Study Start: 2021-03-15
• Study First Submitted QC: 2021-03-15
• Last Update Submitted: 2021-03-15
• Study First Posted: 2021-03-16
• Last Update Posted: 2021-03-16
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

• Patient, male or female, over 18 years of age
• Patient with scheduled major surgery
• Patient with signed consent

Exclusion Criteria

• Protected patient : major under guardianship, tutorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant or breastfeeding woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with scheduled major surgery	Diagnostic test	Patients with scheduled major surgery

Primary Outcome Measures

Name	Time	Method
Complete blood iron status	Preoperative	Transferrin Saturation Factor
Blood iron status	Preoperative	Ferritin