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

Sponsor

VIFORFRANCE (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04800042

Collaborator

(none)

1,700

Enrollment

Arm

6.5

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diagnostic	Diagnostic Test: Diagnostic test	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1700 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with scheduled major surgery Patients with scheduled major surgery	Diagnostic Test: Diagnostic test Blood iron status : ferritin and transferrin saturation factor

Arm

Intervention/Treatment

Other: Patients with scheduled major surgery

Patients with scheduled major surgery

Diagnostic Test: Diagnostic test

Blood iron status : ferritin and transferrin saturation factor

Outcome Measures

Primary Outcome Measures

Blood iron status [Preoperative]
Ferritin
Complete blood iron status [Preoperative]
Transferrin Saturation Factor

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

VIFORFRANCE

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

VIFORFRANCE

ClinicalTrials.gov Identifier:

NCT04800042

Other Study ID Numbers:

CARENFER-PBM

First Posted:

Mar 16, 2021

Last Update Posted:

Mar 16, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anemia, Iron-Deficiency

Study Results

No Results Posted as of Mar 16, 2021