Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

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 Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Drug: Ferinject; Drug: Normal saline

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 Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jung-Wee Park, M.D.; Phone Number: 82-10-2255-7726; Email: jwepark@gmail.com

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of, 13620
    • Recruiting
    • Seoul National University Bundang Hospital
    • Contact: Young-Kyun Lee, M.D.; Phone Number: 82-31-787-7204; Email: ykleemd@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative delirium	The presence and duration of postoperative delirium	since immediately after the surgery to the discharge date

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: JW Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 17, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Leg Injuries; Femoral Fractures; Hip Injuries; Delirium; Fractures, Bone; Hip Fractures
• Other Study ID Numbers: FERINJECT

Drug and device information, study documents

• 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