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Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Primary Purpose

Hip Fractures

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ferinject
Normal saline
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hip Fractures

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ferinject group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative delirium
The presence and duration of postoperative delirium

Secondary Outcome Measures

Postoperative transfusion
The amount of postoperative transfusion
Transfusion-related complications
The presence of transfusion-related complications
Functional outcomes
Postoperative functional outcomes of hip fracture patients
Hematologic outcomes
Postoperative hematologic outcomes of hip fracture patients

Full Information

First Posted
April 17, 2022
Last Updated
June 22, 2022
Sponsor
Seoul National University Bundang Hospital
Collaborators
JW Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT05429749
Brief Title
Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
Official Title
Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
JW Pharmaceutical

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ferinject group
Arm Type
Experimental
Arm Description
This group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
This group of hip fracture patients are treated with normal saline as a control group.
Intervention Type
Drug
Intervention Name(s)
Ferinject
Other Intervention Name(s)
Ferric Carboxymaltose
Intervention Description
Intravenous ferinject 1000mg is administered between the admission day and the surgery day.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline 250ml is administered between the admission day and the surgery day.
Primary Outcome Measure Information:
Title
Postoperative delirium
Description
The presence and duration of postoperative delirium
Time Frame
since immediately after the surgery to the discharge date
Secondary Outcome Measure Information:
Title
Postoperative transfusion
Description
The amount of postoperative transfusion
Time Frame
Postoperative admission datessince immediately after the surgery to the discharge date
Title
Transfusion-related complications
Description
The presence of transfusion-related complications
Time Frame
since immediately after the surgery to the discharge date
Title
Functional outcomes
Description
Postoperative functional outcomes of hip fracture patients
Time Frame
since immediately after the surgery to the discharge date
Title
Hematologic outcomes
Description
Postoperative hematologic outcomes of hip fracture patients
Time Frame
since immediately after the surgery to the discharge date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-Wee Park, M.D.
Phone
82-10-2255-7726
Email
jwepark@gmail.com
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Kyun Lee, M.D.
Phone
82-31-787-7204
Email
ykleemd@gmail.com

12. IPD Sharing Statement

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Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

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