Hip FracturesPhase 4NCT06080893
The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures
A Phase 4 study testing Ferric carboxymaltose in people with Hip Fractures and Anemia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Hip fractures (HF) are the most common and serious pathology affecting the hip and are associated with a high mortality risk in elderly patients. The prevalence of HF is increasing day by day and surgery is often required for its treatment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures, Anemia, Complication,Postoperative
- What is being tested?
- Ferric carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2023to 24 Mar 2025
- 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
- >65 years
Who cannot join
- < 65 years
- Tumor-induced pathological fractures
- Patients undergoing preop ES replacement
- Ferric Carboxymaltose drug allergy
- Multiple trauma
- Receiving iron therapy in any form at the time of application
- Those who cannot come to postop clinical follow-up (out of town, etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology
Istanbul, Çapa / Fatih, 34093
About this study
Hip fractures (HF) are the most common and serious pathology affecting the hip and are associated with a high mortality risk in elderly patients. The prevalence of HF is increasing day by day and surgery is often required for its treatment. Perioperative anemia not only hinders the early recovery and rapid rehabilitation of elderly patients, but also adversely increases the need for blood transfusion, prolongs hospital length of stay (HLS) and even increases the risk of death. Although the blood transfusion threshold is restrictive, approximately one or two thirds of elderly patients with hip fracture surgery (HFS) require blood transfusion during hospitalization, and blood transfusion also has potential side effects.The most important factor in the development of anemia in HF is blood loss; however, there are other mechanisms (renal failure, inflammation, iatrogenic hemodilution) that lead to the selection of different therapeutic approaches.Oral or intravenous iron supplementation is a well-accepted alternative to counteract or prevent perioperative anemia, stimulate erythropoiesis and increase Hgb level in elderly patients. However, there are few studies addressing the relationship between iron therapy and clinical outcomes or mortality. Because ferric carboxymaltose (FCM) allows doses of 2 g in a single session (and can be administered by a short IV infusion of 15-20 minutes), and furthermore, FCM is excellently tolerated and safe for patients. This study was planned to investigate the relationship between FCM supplementation and blood transfusion volume, HLS, postoperative infection and mortality.
Read the detailed description
In the prospective randomized controlled study, a 6 - 12 month follow-up of participants undergoing hip fracture surgery with and without preoperative FCM treatment will be performed. Planning is being made with a total of 200 participants from 100 participants each in the experimental and control groups. Participants over the age of 65 who are diagnosed with hip fracture at Istanbul University Istanbul Faculty of Medicine Orthopedics and Traumatology Clinic will be included in the study. Participants who meet the inclusion criteria will be randomized into 2 groups as participants with and without preopaerative FCM (20 min iv infusion) so as to evaluate laboratory values during hospital stay, perop and postop ES transfusion needs, post-discharge 6th week Hgb value and 6th and 12th month mortality information. The parameters to be examined in clinical controls in the study are age, gender, smoking, comorbidities if any, hip fracture type, surgical treatment, ASA score, body mass index, preop/postop/pre-discharge/6th week Hgb value, perop/postop transfusion amount, preop INR value and 6th month/12th month mortality status.
- Conditions
- Hip Fractures, Anemia, Complication,Postoperative
- Being tested
- Ferric carboxymaltose
- Keywords
- administration, intravenous, aged, anemia / complications, anemia / drug therapy, ferric compounds, hip fractures / mortality, hip fractures / surgery
- Medical subject headings
- Hip Fractures, Anemia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
Also called Ferinject
FCM can be administered in a short IV infusion of 15-20 minutes, allowing doses of 2 g in a single session, and furthermore, FCM is excellently tolerated and safe for patients.
FCM will be administered intravenously at preop 24th hour according to weight and preop hgb level
| Study group | Role | What they receive |
|---|---|---|
| Ferric Carboxymaltose - Administrated Group | Experimental | Patients eligible for inclusion who received preop FCM intravenous therapy
FCM will be administered intravenously at preop 24th hour according to weight and preop hgb level Receives: Drug: Ferric carboxymaltose |
| Ferric Carboxymaltose - Not Administrated Group | No intervention | Patients eligible for inclusion who are not received preop FCM intravenous therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
6th and 12th month mortality information
Measured: 6th and 12th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start10 Oct 2023
- Primary completion10 Jun 2024
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Özkaya, Istanbul University
- Investigators
- Mert Ballı, Study chair, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080893
- Sponsor's protocol ID
- Istanbul Faculty of Medicine
- Status last verified
- Mar 2025
- First submitted
- 8 Oct 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jones JJ, Mundy LM, Blackman N, Shwarz M. Ferric Carboxymaltose for Anemic Perioperative Populations: A Systematic Literature Review of Randomized Controlled Trials. J Blood Med. 2021 May 26;12:337-359. doi: 10.2147/JBM.S295041. eCollection 2021.
PubMed 34079413Clemmensen SZ, Kragholm KH, Melgaard D, Hansen LT, Riis J, Cavallius C, Morch MM, Krogager ML. Association between intravenous iron therapy and short-term mortality risk in older patients undergoing hip fracture surgery: an observational study. J Orthop Surg Res. 2021 May 18;16(1):320. doi: 10.1186/s13018-021-02462-x.
PubMed 34006287Parker MJ. Iron supplementation for anemia after hip fracture surgery: a randomized trial of 300 patients. J Bone Joint Surg Am. 2010 Feb;92(2):265-9. doi: 10.2106/JBJS.I.00883.
PubMed 20124051Bernabeu-Wittel M, Romero M, Ollero-Baturone M, Aparicio R, Murcia-Zaragoza J, Rincon-Gomez M, Monte-Secades R, Melero-Bascones M, Rosso CM, Ruiz-Cantero A; PAHFRAC-01 Investigators. Ferric carboxymaltose with or without erythropoietin in anemic patients with hip fracture: a randomized clinical trial. Transfusion. 2016 Sep;56(9):2199-211. doi: 10.1111/trf.13624. Epub 2016 May 14.
PubMed 27195774Bernabeu-Wittel M, Aparicio R, Romero M, Murcia-Zaragoza J, Monte-Secades R, Rosso C, Montero A, Ruiz-Cantero A, Melero-Bascones M; PAHFRAC-01 investigators. Ferric carboxymaltose with or without erythropoietin for the prevention of red-cell transfusions in the perioperative period of osteoporotic hip fractures: a randomized contolled trial. The PAHFRAC-01 project. BMC Musculoskelet Disord. 2012 Feb 21;13:27. doi: 10.1186/1471-2474-13-27.
PubMed 22353604Munoz M, Gomez-Ramirez S, Auerbach M. Stimulating erythropoiesis before hip fracture repair for reducing blood transfusion: should we change the hemoglobin cutoff level for defining anemia in females? Transfusion. 2016 Sep;56(9):2160-3. doi: 10.1111/trf.13750. No abstract available.
PubMed 27624208
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Ferric Carboxymaltose Administration on Mortality in Geriatric Hip Fractures
- ClinicalTrials.gov ID
- NCT06080893
- Acronym / sponsor ID
- Istanbul Faculty of Medicine
- Conditions
- Hip Fractures, Anemia, Complication,Postoperative
- Keywords
- administration, intravenous, aged, anemia / complications, anemia / drug therapy, ferric compounds, hip fractures / mortality, hip fractures / surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 12 Oct 2023 (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.
Hip fractures (HF) are the most common and serious pathology affecting the hip and are associated with a high mortality risk in elderly patients. The prevalence of HF is increasing day by day and surgery is often required for its treatment. Perioperative anemia not only hinders the early recovery and rapid rehabilitation of elderly patients, but also adversely increases the need for blood transfusion, prolongs hospital length of stay (HLS) and even increases the risk of death. Although the blood transfusion threshold is restrictive, approximately one or two thirds of elderly patients with hip fracture surgery (HFS) require blood transfusion during hospitalization, and blood transfusion also has potential side effects.The most important factor in the development of anemia in HF is blood loss; however, there are other mechanisms (renal failure, inflammation, iatrogenic hemodilution) that lead to the selection of different therapeutic approaches.Oral or intravenous iron supplementation is a well-accepted alternative to counteract or prevent perioperative anemia, stimulate erythropoiesis and increase Hgb level in elderly patients. However, there are few studies addressing the relationship between iron therapy and clinical outcomes or mortality. Because ferric carboxymaltose (FCM) allows doses of 2 g in a single session (and can be administered by a short IV infusion of 15-20 minutes), and furthermore, FCM is excellently tolerated and safe for patients. This study was planned to investigate the relationship between FCM supplementation and blood transfusion volume, HLS, postoperative infection and mortality.
Detailed description
In the prospective randomized controlled study, a 6 - 12 month follow-up of participants undergoing hip fracture surgery with and without preoperative FCM treatment will be performed. Planning is being made with a total of 200 participants from 100 participants each in the experimental and control groups. Participants over the age of 65 who are diagnosed with hip fracture at Istanbul University Istanbul Faculty of Medicine Orthopedics and Traumatology Clinic will be included in the study. Participants who meet the inclusion criteria will be randomized into 2 groups as participants with and without preopaerative FCM (20 min iv infusion) so as to evaluate laboratory values during hospital stay, perop and postop ES transfusion needs, post-discharge 6th week Hgb value and 6th and 12th month mortality information. The parameters to be examined in clinical controls in the study are age, gender, smoking, comorbidities if any, hip fracture type, surgical treatment, ASA score, body mass index, preop/postop/pre-discharge/6th week Hgb value, perop/postop transfusion amount, preop INR value and 6th month/12th month mortality status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Carboxymaltose - Administrated Group | Experimental | Drug: Ferric carboxymaltosePatients eligible for inclusion who received preop FCM intravenous therapy FCM will be administered intravenously at preop 24th hour according to weight and preop hgb level |
| Ferric Carboxymaltose - Not Administrated Group | No intervention | –Patients eligible for inclusion who are not received preop FCM intravenous therapy |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- >65 years
Key exclusion criteria (7 listed)
- < 65 years
- Tumor-induced pathological fractures
- Patients undergoing preop ES replacement
- Ferric Carboxymaltose drug allergy
- Multiple trauma
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 |
|---|---|---|
| Ferric carboxymaltoseAlso: FerinjectFCM can be administered in a short IV infusion of 15-20 minutes, allowing doses of 2 g in a single session, and furthermore, FCM is excellently tolerated and safe for patients. FCM will be administered intravenously at preop 24th hour according to weight and preop hgb level | Drug | Ferric Carboxymaltose - Administrated Group |
Primary outcome
Mortality
Time frame: 6th and 12th months
6th and 12th month mortality information
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Results publication: PubMed 34079413Jones JJ, Mundy LM, Blackman N, Shwarz M. Ferric Carboxymaltose for Anemic Perioperative Populations: A Systematic Literature Review of Randomized Controlled Trials. J Blood Med. 2021 May 26;12:337-359. doi: 10.2147/JBM.S295041. eCollection 2021.
- Results publication: PubMed 34006287Clemmensen SZ, Kragholm KH, Melgaard D, Hansen LT, Riis J, Cavallius C, Morch MM, Krogager ML. Association between intravenous iron therapy and short-term mortality risk in older patients undergoing hip fracture surgery: an observational study. J Orthop Surg Res. 2021 May 18;16(1):320. doi: 10.1186/s13018-021-02462-x.
- Results publication: PubMed 20124051Parker MJ. Iron supplementation for anemia after hip fracture surgery: a randomized trial of 300 patients. J Bone Joint Surg Am. 2010 Feb;92(2):265-9. doi: 10.2106/JBJS.I.00883.
- Results publication: PubMed 27195774Bernabeu-Wittel M, Romero M, Ollero-Baturone M, Aparicio R, Murcia-Zaragoza J, Rincon-Gomez M, Monte-Secades R, Melero-Bascones M, Rosso CM, Ruiz-Cantero A; PAHFRAC-01 Investigators. Ferric carboxymaltose with or without erythropoietin in anemic patients with hip fracture: a randomized clinical trial. Transfusion. 2016 Sep;56(9):2199-211. doi: 10.1111/trf.13624. Epub 2016 May 14.
- Results publication: PubMed 22353604Bernabeu-Wittel M, Aparicio R, Romero M, Murcia-Zaragoza J, Monte-Secades R, Rosso C, Montero A, Ruiz-Cantero A, Melero-Bascones M; PAHFRAC-01 investigators. Ferric carboxymaltose with or without erythropoietin for the prevention of red-cell transfusions in the perioperative period of osteoporotic hip fractures: a randomized contolled trial. The PAHFRAC-01 project. BMC Musculoskelet Disord. 2012 Feb 21;13:27. doi: 10.1186/1471-2474-13-27.
- Results publication: PubMed 27624208Munoz M, Gomez-Ramirez S, Auerbach M. Stimulating erythropoiesis before hip fracture repair for reducing blood transfusion: should we change the hemoglobin cutoff level for defining anemia in females? Transfusion. 2016 Sep;56(9):2160-3. doi: 10.1111/trf.13750. No abstract available.
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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.
Mert Ballı study chair
Istanbul Faculty of Medicine
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 Ferric carboxymaltose in people with Hip Fractures and Anemia, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 26 Mar 2025. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6th and 12th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06080893, which also lists 6 linked publications.
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 26 Mar 2025.