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DFACCVM: Iron Deficiency and Anemia in Cardiac Surgery

Sponsor
Centre Hospitalier Régional Metz-Thionville (Other)
Overall Status
Recruiting
CT.gov ID
NCT04980911
Collaborator
(none)
320
Enrollment
1
Location
20.6
Anticipated Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    320 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Iron Deficiency and Anemia in Cardiovascular Surgery
    Actual Study Start Date :
    Apr 12, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Number of transfusion [Day 7]

      number of perioperative and post-operative transfusion

    Secondary Outcome Measures

    1. Number of post operative complications [Day 7]

      Number of post-operative complications

    2. Percentage of death [Day 7]

      Percentage of post-operative death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHR Metz Thionville Metz Moselle France 57085

    Sponsors and Collaborators

    • Centre Hospitalier Régional Metz-Thionville

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Régional Metz-Thionville
    ClinicalTrials.gov Identifier:
    NCT04980911
    Other Study ID Numbers:
    • 2021-02Obs-CHRMT
    First Posted:
    Jul 28, 2021
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Anemia

    Study Results

    No Results Posted as of Jul 28, 2021