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

NCT ID: NCT04800042

Last Updated: 2021-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2021-09-30

Brief Summary

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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

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Conditions

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Diagnostic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with scheduled major surgery

Patients with scheduled major surgery

Group Type OTHER

Diagnostic test

Intervention Type DIAGNOSTIC_TEST

Blood iron status : ferritin and transferrin saturation factor

Interventions

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Diagnostic test

Blood iron status : ferritin and transferrin saturation factor

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VIFORFRANCE

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Capdevila X, Lasocki S, Duchalais A, Rigal JC, Mertl P, Ghewy P, Farizon F, Lanz T, Buckert A, Belarbia S, Trochu JN, Cacoub P. Perioperative Iron Deficiency in Patients Scheduled for Major Elective Surgeries: A French Prospective Multicenter Cross-Sectional Study. Anesth Analg. 2023 Aug 1;137(2):322-331. doi: 10.1213/ANE.0000000000006445. Epub 2023 Mar 7.

Reference Type DERIVED
PMID: 36881542 (View on PubMed)

Other Identifiers

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CARENFER-PBM

Identifier Type: -

Identifier Source: org_study_id

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