Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Phase 4

Recruiting

• Conditions: Hip Fractures
• Interventions: Drug: Ferinject; Drug: Normal saline

• Registration Number: NCT05429749
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2020-07-30
• Study First Submitted: 2022-04-17
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-22
• Last Update Submitted: 2022-06-22
• Study First Posted: 2022-06-23
• Last Update Posted: 2022-06-23
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferinject group	Ferinject	This group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day.
Control group	Normal saline	This group of hip fracture patients are treated with normal saline as a control group.

Primary Outcome Measures

Name	Time	Method
Postoperative delirium	since immediately after the surgery to the discharge date	The presence and duration of postoperative delirium

Secondary Outcome Measures

Name	Time	Method
Functional outcomes	since immediately after the surgery to the discharge date	Postoperative functional outcomes of hip fracture patients
Transfusion-related complications	since immediately after the surgery to the discharge date	The presence of transfusion-related complications
Hematologic outcomes	since immediately after the surgery to the discharge date	Postoperative hematologic outcomes of hip fracture patients
Postoperative transfusion	Postoperative admission datessince immediately after the surgery to the discharge date	The amount of postoperative transfusion

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of