Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Seoul National University

Status and phase: Enrolling; Phase 4

Conditions: Hip Fractures

Treatments: Drug: Normal saline; Drug: Ferinject

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05429749

Ferinject

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

Ferinject group

Experimental group

Description:

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

Treatment:

Drug: Ferinject

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Normal saline