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NCT04980911 Clinical Trial

Iron Deficiency and Anemia in Cardiac Surgery

Anemia Clinical Trial

— DFACCVM  

Official title:
Iron Deficiency and Anemia in Cardiovascular Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04980911
Other study ID # 2021-02Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2021
Est. completion date March 18, 2022

Study information
Verified date August 2022
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Anemia and preoperative iron deficit in cardiac surgery are associated by an increased volume of transfusion and an increase in complications and/or mortality. Recent studies have shown that EPO and iron administration the days preceding the operation results in a reduction of perioperative transfusion for patients with preoperative anemia.

Recruitment information / eligibility
Status Completed
Enrollment 1711
Est. completion date March 18, 2022
Est. primary completion date March 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with cardiac surgery - With iron deficiency with or without anemia Exclusion Criteria: - Anemia without iron deficiency - Iron overload - Jehovah's witnesses - Endocarditis - Treating neoplasia - Uncontrolled hypertension - With infection - Alfa-epoetin hypersensitivity - Hypersensitivity of hamster's protein - Erythroblastopenia induced by erythropoietin - Ferinject or mannitol allergy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France CHR Metz Thionville Metz Moselle

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of transfusion number of perioperative and post-operative transfusion Day 7
Secondary Number of post operative complications Number of post-operative complications Day 7
Secondary Percentage of death Percentage of post-operative death Day 7
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