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The safety and efficacy of an accelerated iron sucrose dosing regimen in patients with iron deficiency anemia

The safety and efficacy of an accelerated iron sucrose dosing regimen in patients with iron deficiency anemia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085985
Enrollment
Unknown
Registered
2024-06-21
Start date
2024-06-24
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

iron deficiency anemia

Interventions

Accelerating group:Iron sucrose injection 200mg intravenously daily until infusion of the estimated total iron deficiency dose
Conventional group:Iron sucrose injection 200mg intravenously, administered 3 times a week until the estimated total iron deficiency dose was transfused

Sponsors

the First People’s Hospital of Xining
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years old; (2) Able to sign informed consent; (3) History of oral iron intolerance or no response; (4) Individuals with moderate to severe iron deficiency anemia caused by different etiologies, such as chronic inflammation, gynecological diseases, gastrointestinal diseases, heart failure, and insufficient iron intake.

Exclusion criteria

Exclusion criteria: (1) Anemia caused mainly by factors other than iron deficiency (such as megaloblastic anemia, hemolytic anemia); (2) Allergic to iron sucrose injection in the past; (3) Pregnant and lactating women; (4) Serum ferritin (SF) > 700ng/mL and/or TSAT > 50%; (5) Patients with other serious diseases (including active infection, active bleeding, malignancy, hematologic malignancy, CKD, severe heart failure (NYHA Class III or IV), severe liver disease); (6) Patients who had received blood transfusion and erythropoietin treatment within 30 days before enrollment; (7) Patients who had received intravenous iron infusion within 10 days before enrollment; (8) Patients who underwent surgery 30 days before enrollment or who might require general anesthesia during the trial. (9) Any other laboratory abnormality, medical condition, or mental disorder that the investigator believes may jeopardize the treatment of the subject's disease or may cause the subject to be unable to comply with the study requirements.

Design outcomes

Primary

MeasureTime frame
hemoglobin;Complex cardiovascular adverse event incidence;

Secondary

MeasureTime frame
Absolute reticulocyte count;Serum iron;ferritin;The time of the first composite cardiovascular adverse event;Number of allergic patients;Number of cases of phlebitis and rash;

Countries

China

Contacts

Public ContactXiaolong YUAN

the First People’s Hospital of Xining

1028127879@qq.com+86 180 9578 0320

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026