Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
1 other identifier
interventional
264
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2020
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2020
CompletedFirst Submitted
Initial submission to the registry
April 17, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 23, 2022
June 1, 2022
3.4 years
April 17, 2022
June 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative delirium
The presence and duration of postoperative delirium
since immediately after the surgery to the discharge date
Secondary Outcomes (4)
Postoperative transfusion
Postoperative admission datessince immediately after the surgery to the discharge date
Transfusion-related complications
since immediately after the surgery to the discharge date
Functional outcomes
since immediately after the surgery to the discharge date
Hematologic outcomes
since immediately after the surgery to the discharge date
Study Arms (2)
Ferinject group
EXPERIMENTALThis group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day.
Control group
ACTIVE COMPARATORThis group of hip fracture patients are treated with normal saline as a control group.
Interventions
Intravenous ferinject 1000mg is administered between the admission day and the surgery day.
Normal saline 250ml is administered between the admission day and the surgery day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Bundang Hospitallead
- JW Pharmaceuticalcollaborator
Study Sites (1)
Seoul National University Bundang Hospital
Seongnam, 13620, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 17, 2022
First Posted
June 23, 2022
Study Start
July 30, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
June 23, 2022
Record last verified: 2022-06