Hip FracturesPhase 4NCT05429749
Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
A Phase 4 study testing Ferinject and Normal saline in people with Hip Fractures, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Ferinject and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jul 2020to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
Young-Kyun Lee, M.D., 82-31-787-7204, ykleemd@gmail.com
About this study
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.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Ferinject, Normal saline
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDrug
Also called Ferric Carboxymaltose
Intravenous ferinject 1000mg is administered between the admission day and the surgery day.
Normal salineDrug
Normal saline 250ml is administered between the admission day and the surgery day.
| Study group | Role | What they receive |
|---|---|---|
| Ferinject group | Experimental | This group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day. Receives: Drug: Ferinject |
| Control group | Active comparator | This group of hip fracture patients are treated with normal saline as a control group. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium
The presence and duration of postoperative delirium
Measured: since immediately after the surgery to the discharge date
Secondary outcomes (4)
Postoperative transfusion
The amount of postoperative transfusion
Measured: Postoperative admission datessince immediately after the surgery to the discharge date
Transfusion-related complications
The presence of transfusion-related complications
Measured: since immediately after the surgery to the discharge date
Functional outcomes
Postoperative functional outcomes of hip fracture patients
Measured: since immediately after the surgery to the discharge date
Hematologic outcomes
Postoperative hematologic outcomes of hip fracture patients
Measured: since immediately after the surgery to the discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start30 Jul 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- JW Pharmaceutical
- Responsible party
- Principal investigator, Young-Kyun Lee, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429749
- Sponsor's protocol ID
- Ferinject
- Status last verified
- Jun 2022
- First submitted
- 17 Apr 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Iron Supplement to Prevent Postoperative Delirium After Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT05429749
- Acronym / sponsor ID
- Ferinject
- Conditions
- Hip Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- JW Pharmaceutical
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferinject group | Experimental | Drug: FerinjectThis group of hip fracture patients are treated with intravenous Ferinject between the admission and the surgery day. |
| Control group | Active comparator | Drug: Normal salineThis group of hip fracture patients are treated with normal saline as a control group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerinjectAlso: Ferric CarboxymaltoseIntravenous ferinject 1000mg is administered between the admission day and the surgery day. | Drug | Ferinject group |
| Normal salineNormal saline 250ml is administered between the admission day and the surgery day. | Drug | Control group |
Primary outcome
Postoperative delirium
Time frame: since immediately after the surgery to the discharge date
The presence and duration of postoperative delirium
4 secondary outcomes
Postoperative transfusion
Time frame: Postoperative admission datessince immediately after the surgery to the discharge date
Transfusion-related complications
Time frame: since immediately after the surgery to the discharge date
Functional outcomes
Time frame: since immediately after the surgery to the discharge date
Hematologic outcomes
Time frame: since immediately after the surgery to the discharge date
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferinject and Normal saline in people with Hip Fractures, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Wee Park, M.D. (82-10-2255-7726, jwepark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium (time frame: since immediately after the surgery to the discharge date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.