Intravenous Iron Supplement to Prevent Postoperative Deli... | NCT05429749

Studies
Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery

NCT05429749

Sponsor

Seoul National University Bundang Hospital

Status

Unknown status

Last Update Posted

Jun 23, 2022Actual

Enrollment

264Estimated

Phase

Phase 4

Conditions

Hip Fractures

Interventions

Ferinject
Normal saline

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 30, 2020Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 17, 2022

First Submission Date that Met QC Criteria

Jun 22, 2022

First Posted Date

Jun 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2022

Last Update Posted Date

Jun 23, 2022Actual

Name	Class
JW Pharmaceutical	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

264Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ferinject group	Experimental	This group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day.	Drug: Ferinject
Control group	Active Comparator	This group of hip fracture patients are treated with normal saline as a control group.	Drug: Normal saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ferinject	Drug	Intravenous ferinject 1000mg is administered between the admission day and the surgery day.	Ferinject group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative delirium	The presence and duration of postoperative delirium	since immediately after the surgery to the discharge date

Secondary Outcomes

Measure	Description	Time Frame
Postoperative transfusion	The amount of postoperative transfusion	Postoperative admission datessince immediately after the surgery to the discharge date
Transfusion-related complications	The presence of transfusion-related complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jung-Wee Park, M.D.	Contact	82-10-2255-7726		jwepark@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital	Recruiting	Seongnam		13620	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006620	Hip Fractures

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D025981	Hip Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522335	ferric carboxymaltose
D000077330	Saline Solution

Ancestor Terms

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided