Ferric CarboxymaltosePITAMLFENCT07057973
The Effectiveness of Preoperative Iron Therapy in Improving Anemia After Multi-level Lumbar Fusion in the Elderly
A study testing Ferric carboxymaltose in people with Ferric Carboxymaltose, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ferric Carboxymaltose
- What is being tested?
- Ferric carboxymaltose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients underwent multi-segment lumbar spine surgery;
- IDA patients aged 65 years or older (male: Hb < 120g/dL; female: Hb < 110g/dL);
- All patients completed the relevant questionnaire survey;
Who cannot join
- Age less than 65 years old;
- Previous surgery for spinal tumors, trauma or infection;
- Inflammatory or immune diseases (such as rheumatoid arthritis or systemic lupus erythematosus), acute kidney injury, progressive cancer and porphyria cutanea tarda);
- Non-adjacent segment surgery;
- History of allergy to ferric carboxymaltose or any intravenous iron preparations, asthma, atopic dermatitis or allergy;
- Decompensated cirrhosis and microcytic anemia;
- Incomplete clinical data;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 10053
Qingyang Huang, 18205570261, huangqingyang@163.com
About this study
Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. International studies provide high-level evidence-based evidence for intravenous iron, but lack spinal surgery-specific data; domestic studies focus on the comparison of iron types and the improvement of clinical practice, but high-quality evidence is still insufficient. At present, there are still few studies on preoperative iron therapy in the field of spinal surgery, especially its specific impact on the prognosis of patients after lumbar fusion surgery is still unclear. Therefore, it is particularly important to study the preoperative iron supplementation regimen for lumbar fusion surgery to improve the efficacy and safety. Through multidisciplinary collaboration and technological innovation, preoperative iron therapy is expected to become an important part of accelerated recovery after lumbar fusion surgery.
Read the detailed description
Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. International studies provide high-level evidence-based evidence for intravenous iron, but lack spinal surgery-specific data; domestic studies focus on the comparison of iron types and the improvement of clinical practice, but high-quality evidence is still insufficient. At present, there are still few studies on preoperative iron therapy in the field of spinal surgery, especially its specific impact on the prognosis of patients after lumbar fusion surgery is still unclear. Therefore, it is particularly important to study the preoperative iron supplementation regimen for lumbar fusion surgery to improve the efficacy and safety. Through multidisciplinary collaboration and technological innovation, preoperative iron therapy is expected to become an important part of accelerated recovery after lumbar fusion surgery.
This study aimed to investigate the correlation between ferric carboxymaltose and iron deficiency anemia (IDA) patients with or without concurrent iron therapy on hemoglobin changes, 90-day adverse events, and satisfactory health-related quality of life (HRQOL) indicators after multilevel lumbar spine fusion.
Outcome measures
- Differences in hemoglobin and iron metabolism indicators (serum iron, ferritin, transferrin, transferrin saturation) levels on the 1st, 4th, 7th day after surgery and at discharge
- Differences in the incidence of adverse events and length of hospital stay within 90 days after lumbar multilevel fusion surgery Any adverse event (AAE): serious or minor adverse event Serious adverse events (SAE): pulmonary embolism, wound infection, deep vein thrombosis, sepsis, myocardial infarction, neurological complications, delirium, septic shock, reoperation Minor adverse events (MAE): wound dehiscence, hematoma, other wound complications, acute kidney injury, blood transfusion, cerebrospinal fluid leak, urinary tract infection, pneumonia
- Study-specific surveys conducted at the time of assessment included the following health status-related quality of life scores (HRQOL): Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and EuroQol-5D (EQ-5D), 36-Item Short Form Health Survey (SF-36)
- Conditions
- Ferric Carboxymaltose
- Being tested
- Ferric carboxymaltose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
The experimental group was treated with 1000 mg of ferric carboxymaltose
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Placebo treatment |
| Ferric carboxymaltose | Experimental | Ferric carboxymaltose treatment Receives: Drug: Ferric carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
the levels of hemoglobin
the levels of hemoglobin
Measured: on the first, fourth, and seventh days after surgery and at four weeks
the level of iron metabolism indicators (serum iron, ferritin, transferrin, and transferrin saturation)
the level of iron metabolism indicators (serum iron, ferritin, transferrin, and transferrin saturation)
Measured: on the first, fourth, and seventh days after surgery and at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ferric CarboxymaltoseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057973
- Sponsor's protocol ID
- Xuanwu_DLD
- Acronym
- PITAMLFE
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Preoperative Iron Therapy in Improving Anemia After Multi-level Lumbar Fusion in the Elderly
- ClinicalTrials.gov ID
- NCT07057973
- Acronym / sponsor ID
- PITAMLFE / Xuanwu_DLD
- Conditions
- Ferric Carboxymaltose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 10 Jul 2025 (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.
Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. International studies provide high-level evidence-based evidence for intravenous iron, but lack spinal surgery-specific data; domestic studies focus on the comparison of iron types and the improvement of clinical practice, but high-quality evidence is still insufficient. At present, there are still few studies on preoperative iron therapy in the field of spinal surgery, especially its specific impact on the prognosis of patients after lumbar fusion surgery is still unclear. Therefore, it is particularly important to study the preoperative iron supplementation regimen for lumbar fusion surgery to improve the efficacy and safety. Through multidisciplinary collaboration and technological innovation, preoperative iron therapy is expected to become an important part of accelerated recovery after lumbar fusion surgery.
Detailed description
Preoperative iron therapy has important value in improving the outcomes after lumbar fusion surgery, but there is significant heterogeneity in both domestic and international studies. International studies provide high-level evidence-based evidence for intravenous iron, but lack spinal surgery-specific data; domestic studies focus on the comparison of iron types and the improvement of clinical practice, but high-quality evidence is still insufficient. At present, there are still few studies on preoperative iron therapy in the field of spinal surgery, especially its specific impact on the prognosis of patients after lumbar fusion surgery is still unclear. Therefore, it is particularly important to study the preoperative iron supplementation regimen for lumbar fusion surgery to improve the efficacy and safety. Through multidisciplinary collaboration and technological innovation, preoperative iron therapy is expected to become an important part of accelerated recovery after lumbar fusion surgery.
This study aimed to investigate the correlation between ferric carboxymaltose and iron deficiency anemia (IDA) patients with or without concurrent iron therapy on hemoglobin changes, 90-day adverse events, and satisfactory health-related quality of life (HRQOL) indicators after multilevel lumbar spine fusion.
Outcome measures
- Differences in hemoglobin and iron metabolism indicators (serum iron, ferritin, transferrin, transferrin saturation) levels on the 1st, 4th, 7th day after surgery and at discharge
- Differences in the incidence of adverse events and length of hospital stay within 90 days after lumbar multilevel fusion surgery Any adverse event (AAE): serious or minor adverse event Serious adverse events (SAE): pulmonary embolism, wound infection, deep vein thrombosis, sepsis, myocardial infarction, neurological complications, delirium, septic shock, reoperation Minor adverse events (MAE): wound dehiscence, hematoma, other wound complications, acute kidney injury, blood transfusion, cerebrospinal fluid leak, urinary tract infection, pneumonia
- Study-specific surveys conducted at the time of assessment included the following health status-related quality of life scores (HRQOL): Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and EuroQol-5D (EQ-5D), 36-Item Short Form Health Survey (SF-36)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Placebo treatment |
| Ferric carboxymaltose | Experimental | Drug: Ferric carboxymaltoseFerric carboxymaltose treatment |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients underwent multi-segment lumbar spine surgery;
- IDA patients aged 65 years or older (male: Hb < 120g/dL; female: Hb < 110g/dL);
- All patients completed the relevant questionnaire survey;
Key exclusion criteria (7 listed)
- Age less than 65 years old;
- Previous surgery for spinal tumors, trauma or infection;
- Inflammatory or immune diseases (such as rheumatoid arthritis or systemic lupus erythematosus), acute kidney injury, progressive cancer and porphyria cutanea tarda);
- Non-adjacent segment surgery;
- History of allergy to ferric carboxymaltose or any intravenous iron preparations, asthma, atopic dermatitis or allergy;
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 carboxymaltoseThe experimental group was treated with 1000 mg of ferric carboxymaltose | Drug | Ferric carboxymaltose |
Primary outcome
the levels of hemoglobin
Time frame: on the first, fourth, and seventh days after surgery and at four weeks
the levels of hemoglobin
the level of iron metabolism indicators (serum iron, ferritin, transferrin, and transferrin saturation)
Time frame: on the first, fourth, and seventh days after surgery and at 4 weeks
the level of iron metabolism indicators (serum iron, ferritin, transferrin, and transferrin saturation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferric carboxymaltose in people with Ferric Carboxymaltose, run by Xuanwu Hospital, Beijing at 1 site in China.
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 3 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: looking for participants now, as of the sponsor's last update on 10 Jul 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 China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the levels of hemoglobin (time frame: on the first, fourth, and seventh days after surgery and at four weeks). The study lists 2 primary outcomes in all. 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 10 Jul 2025.