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NCT05429749 Clinical Trial

Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Hip Fractures Clinical Trial

Official title:
Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05429749
Other study ID # Ferinject
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 30, 2020
Est. completion date December 31, 2024

Study information
Verified date June 2022
Source Seoul National University Bundang Hospital
Contact Jung-Wee Park, M.D.
Phone 82-10-2255-7726
Email jwepark@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 264
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Ferinject
Intravenous ferinject 1000mg is administered between the admission day and the surgery day.
• Normal saline
Normal saline 250ml is administered between the admission day and the surgery day.

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam

Sponsors (2)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative delirium The presence and duration of postoperative delirium since immediately after the surgery to the discharge date
Secondary Postoperative transfusion The amount of postoperative transfusion Postoperative admission datessince immediately after the surgery to the discharge date
Secondary Transfusion-related complications The presence of transfusion-related complications since immediately after the surgery to the discharge date
Secondary Functional outcomes Postoperative functional outcomes of hip fracture patients since immediately after the surgery to the discharge date
Secondary Hematologic outcomes Postoperative hematologic outcomes of hip fracture patients since immediately after the surgery to the discharge date
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