Hip Fractures
Conditions
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.
Interventions
DRUGFerinject
Intravenous ferinject 1000mg is administered between the admission day and the surgery day.
DRUGNormal saline
Normal saline 250ml is administered between the admission day and the surgery day.
Sponsors
JW Pharmaceutical
Seoul National University Bundang Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative delirium | since immediately after the surgery to the discharge date | The presence and duration of postoperative delirium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative transfusion | Postoperative admission datessince immediately after the surgery to the discharge date | The amount of postoperative transfusion |
| Transfusion-related complications | since immediately after the surgery to the discharge date | The presence of transfusion-related complications |
| Functional outcomes | since immediately after the surgery to the discharge date | Postoperative functional outcomes of hip fracture patients |
| Hematologic outcomes | since immediately after the surgery to the discharge date | Postoperative hematologic outcomes of hip fracture patients |
Countries
South Korea
Contacts
Primary ContactJung-Wee Park, M.D.
Outcome results
None listed