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

Diagnostic Clinical Trial

— CARENFER-PBM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04800042
• Other study ID #: CARENFER-PBM
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2021
• Source: VIFORFRANCE
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1700
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Diagnostic

Intervention

Diagnostic Test:
• Diagnostic test
Blood iron status : ferritin and transferrin saturation factor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VIFORFRANCE

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood iron status	Ferritin	Preoperative
Primary	Complete blood iron status	Transferrin Saturation Factor	Preoperative