Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 10053, China
Location status: Recruiting
NCT Number: NCT07057973
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.
Interested in participating?
Request Info60 year–90 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 10053, China
Location status: Recruiting
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The experimental group was treated with 1000 mg of ferric carboxymaltose
Time frame: on the first, fourth, and seventh days after surgery and at four weeks
the levels of hemoglobin
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)
Xuanwu Hospital, Beijing
Other
Acronym: PITAMLFE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06958822
Anemia, Anemia, Hypochromic
Adana, Turkey (Türkiye)
View Trial Details