Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2023

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.

Interventions

  • Drug: Ferinject
    • Intravenous ferinject 1000mg is administered between the admission day and the surgery day.
  • Drug: Normal saline
    • Normal saline 250ml is administered between the admission day and the surgery day.

Arms, Groups and Cohorts

  • Experimental: Ferinject group
    • This group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day.
  • Active Comparator: Control group
    • This group of hip fracture patients are treated with normal saline as a control group.

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative delirium
    • Time Frame: since immediately after the surgery to the discharge date
    • The presence and duration of postoperative delirium

Secondary Measures

  • Postoperative transfusion
    • Time Frame: Postoperative admission datessince immediately after the surgery to the discharge date
    • The amount of postoperative transfusion
  • Transfusion-related complications
    • Time Frame: since immediately after the surgery to the discharge date
    • The presence of transfusion-related complications
  • Functional outcomes
    • Time Frame: since immediately after the surgery to the discharge date
    • Postoperative functional outcomes of hip fracture patients
  • Hematologic outcomes
    • Time Frame: since immediately after the surgery to the discharge date
    • Postoperative hematologic outcomes of hip fracture patients

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Bundang Hospital
  • Collaborator
    • JW Pharmaceutical
  • Provider of Information About this Clinical Study
    • Principal Investigator: Young-Kyun Lee, Professor – Seoul National University Bundang Hospital
  • Overall Contact(s)
    • Jung-Wee Park, M.D., 82-10-2255-7726, jwepark@gmail.com

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