Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

NCT ID: NCT05429749

Last Updated: 2022-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-30

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Hip Fractures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ferinject group

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

Group Type EXPERIMENTAL

Ferinject

Intervention Type DRUG

Intravenous ferinject 1000mg is administered between the admission day and the surgery day.

Control group

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

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline 250ml is administered between the admission day and the surgery day.

Interventions

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Ferinject

Intravenous ferinject 1000mg is administered between the admission day and the surgery day.

Intervention Type DRUG

Normal saline

Normal saline 250ml is administered between the admission day and the surgery day.

Intervention Type DRUG

Other Intervention Names

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Ferric Carboxymaltose

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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JW Pharmaceutical

INDUSTRY

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young-Kyun Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jung-Wee Park, M.D.

Role: CONTACT

82-10-2255-7726

Facility Contacts

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Young-Kyun Lee, M.D.

Role: primary

82-31-787-7204

Other Identifiers

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Ferinject

Identifier Type: -

Identifier Source: org_study_id

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