Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Study Overview
=================
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.

Official Title
-----------------
Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Conditions
-----------------
Hip Fractures

Intervention / Treatment
-----------------
* Drug: Ferinject
* Drug: Normal saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferinject group<br>This group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day. | Drug: Ferinject<br>* Intravenous ferinject 1000mg is administered between the admission day and the surgery day.<br>* Other names: Ferric Carboxymaltose;|
| Active Comparator: Control group<br>This group of hip fracture patients are treated with normal saline as a control group. | Drug: Normal saline<br>* Normal saline 250ml is administered between the admission day and the surgery day.<br>|

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 |