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
About this trial
This is an interventional prevention trial for Hip Fractures
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
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
NCT ID
NCT05429749
First Posted
April 17, 2022
Last Updated
June 22, 2022
Sponsor
Seoul National University Bundang Hospital
Collaborators
JW Pharmaceutical
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
Learn more about this trial
Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
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