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Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05429749
Collaborator
JW Pharmaceutical (Industry)
264
Enrollment
1
Location
2
Arms
53.1
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a clinical trial to evaluate the effect of intravenous iron supplement with Ferinject (Ferric Carboxymaltose) in preventing postoperative delirium after hip fracture surgery.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

We hypothesized that IV iron supplement will (1) decrease postoperative delirium in hip fracture patients and (2) decrease the amount of transfusion and transfusion-related complications.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
264 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
Actual Study Start Date :
Jul 30, 2020
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ferinject group

This group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day.

Drug: Ferinject
Intravenous ferinject 1000mg is administered between the admission day and the surgery day.
Other Names:
  • Ferric Carboxymaltose

    		•
    Active Comparator: Control group

    This group of hip fracture patients are treated with normal saline as a control group.

    Drug: Normal saline
    Normal saline 250ml is administered between the admission day and the surgery day.

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative delirium [since immediately after the surgery to the discharge date]

      The presence and duration of postoperative delirium

    Secondary Outcome Measures

    1. Postoperative transfusion [Postoperative admission datessince immediately after the surgery to the discharge date]

      The amount of postoperative transfusion

    2. Transfusion-related complications [since immediately after the surgery to the discharge date]

      The presence of transfusion-related complications

    3. Functional outcomes [since immediately after the surgery to the discharge date]

      Postoperative functional outcomes of hip fracture patients

    4. Hematologic outcomes [since immediately after the surgery to the discharge date]

      Postoperative hematologic outcomes of hip fracture patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • femur neck fracture, intertrochanteric fractures

    • Iron deficiency anemia (Hb<12 in women, Hb<13 in men)

    • Iron deficiency (Serum ferritin <100ug/L or transferrin saturation<20%)

    • Who understands this clinical trial and volunteers and agrees to this trial

    Exclusion Criteria:

    • Patient under the age of 65 years

    • Hb<7 or someone who has acute symptom of anemia(tachycardia, dyspnea, or dizziness)

    • High energy trauma

    • Preoperative delirium

    • MMSE<10

    • Underlying disease which involves cognitive dysfunction (e.g. neurovascular diseases, acute myocardial infarction, pulmonary embolism)

    • Those who are inappropriate to participate in the clinical trial assessed by the investigators

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam Korea, Republic of 13620

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital
    • JW Pharmaceutical

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Young-Kyun Lee, Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT05429749
    Other Study ID Numbers:
    • Ferinject
    First Posted:
    Jun 23, 2022
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Delirium
    Fractures, Bone
    Hip Fractures

    Study Results

    No Results Posted as of Jun 23, 2022