NCT04800042

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).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

4 months

First QC Date

March 9, 2021

Last Update Submit

March 15, 2021

Conditions

Diagnostic

Outcome Measures

Primary Outcomes (2)

  • Blood iron status

    Ferritin

    Preoperative

  • Complete blood iron status

    Transferrin Saturation Factor

    Preoperative

Study Arms (1)

Patients with scheduled major surgery

OTHER

Patients with scheduled major surgery

Diagnostic Test: Diagnostic test

Interventions

Diagnostic testDIAGNOSTIC_TEST

Blood iron status : ferritin and transferrin saturation factor

Patients with scheduled major surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36881542DERIVED

MeSH Terms

Conditions

Disease

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 16, 2021

Study Start

March 15, 2021

Primary Completion

June 30, 2021

Study Completion

September 30, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share