NCT07057973

Recruiting

The Effectiveness of Preoperative Iron Therapy in Improving ...

Xuanwu Hospital, Beijing Source

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Other study identifiers

Sponsor study identifier

Xuanwu_DLD

Study Type

interventional

Estimated enrollment

100

Locations

1 country

Sites

1

Timeline

Study Start

July 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

July 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

July 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Brief 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. 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 100 participants
Study completion date: July 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 2, 2025
Actual (reported)
Study Start
July 1, 2025
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
First Posted
July 10, 2025
Actual (reported)
Primary Completion
July 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: July 10, 2025
Status Verified: June 2025
Last Update Submitted: June 30, 2025

Conditions

Ferric Carboxymaltose

Outcome Measures

Primary Outcomes (2)

the levels of hemoglobin
the levels of hemoglobin
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)
on the first, fourth, and seventh days after surgery and at 4 weeks

Study Arms (2)

Control group

NO INTERVENTION

Placebo treatment

Ferric carboxymaltose

EXPERIMENTAL

Ferric carboxymaltose treatment

Drug: Ferric carboxymaltose

Interventions

Ferric carboxymaltoseDrug

The experimental group was treated with 1000 mg of ferric carboxymaltose

Ferric carboxymaltose

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age60 Years - 90 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

All patients underwent multi-segment lumbar spine surgery;
IDA patients aged 65 years or older (male: Hb \< 120g/dL; female: Hb \< 110g/dL);

Sponsors & Collaborators

Xuanwu Hospital, Beijing
Otherlead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 10053, China

RECRUITING

Qingyang HuangCONTACT18205570261 huangqingyang@163.com

MeSH Terms

Interventions

ferric carboxymaltose

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 2, 2025

First Posted

July 10, 2025

Study Start

July 1, 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

July 1, 2026

Estimated (date passed)

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Phase 2/3Recruiting

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Phase 1Completed

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Phase 1Recruiting

NCT06080555

Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia

Phase 1Completed

NCT07115121

Comparison of the Mean Change in Hemoglobin With Ferric Carboxymaltose and IV Iron Sucrose in Anemic Antenatal Patients

Not ApplicableCompleted

NCT07476859

Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome

Phase 4Recruiting

All patients completed the relevant questionnaire survey;

You may not qualify if:

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;

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

July 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

July 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT07057973
Data provider: ClinicalTrials.gov
Source updated: 2025-07-10
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:45 UTC

Locations

CN(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Control group

Ferric carboxymaltose

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations