Evaluation of the Role of Preoperative Intravenous Iron in Patients Undergoing Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Analyze levels of Hemoglobine
研究概览
简要总结
The prevalence of preoperative anaemia in patients undergoing major surgery is approximately 30%, and is independently associated with higher mortality, a higher rate of postoperative complications, and a greater probability of receiving a transfusion. In a prehabilitation program, the evaluation and correction of anaemia in the preoperative period is essential, as it is a risk factor for transfusions and complications. The main objectives of this study were to analyse the need for blood transfusion, post-surgical complications, hospital length of stay, ICU length of stay, hospital readmissions, and surgical wound infection in patients treated with ferric carboxymaltose (FC) before surgery. A total of 152 patients were included, of whom 96 received FC before the intervention and 56 received no treatment (control group).
详细描述
It was conducted a prospective pre-post interventional study between 1 January 2019 and 31 December 2022 at Infanta Cristina University Hospital in Parla (Madrid, Spain).
Written informed consent was obtained from each participant. To ensure anonymity and confidentiality, patient data were coded and stored in secure, password-protected databases accessible only to authorized research personnel, in compliance with Spanish legislation (Organic Law 3/2018 and RD 1090/2015).
The data used in the study were anonymous and collected by impartial, unpaid, volunteers.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years; on the SWL.
- •Hemoglobine <13g/dL.
- •Referred for major elective surgery requiring hospital admission (e.g., oncologic resections such as mastectomy, colon resection, nephrectomy, hysterectomy), typically involving general anesthesia and moderate to high morbidity risk, capable of understanding and consenting to the study
- •Physically and mentally able to complete assessments
排除标准
- •Patients with hypersensitivity to FC, or any of its excipients. • Patients with active bleeding
研究组 & 干预措施
Interventional group (Surgical prehabilitation)
This group received standardized care and assessments in a surgical prehabilitation consultation, including preoperative blood tests, correction of conditions such as anemia (including intravenous iron), and the necessary supplementation to optimize the patients.
干预措施: Ferric Carboxymaltose (FCM) (Drug)
结局指标
主要结局
Analyze levels of Hemoglobine
时间窗: From Jan 2019 to Dec 2022
To analyze the levels of: Hemoglobin (Hb) g/dL at three time points: Before the administration of intravenous ferric carboxymaltose (FCM), At the time of inclusion on the surgical waiting list, 30 days after surgery. And to compare the incidence of postoperative complications between patients who received FC and those who did not.
Analyze levels of ferritin
时间窗: From Jan 2019 to Dec 2022
To analyze the levels of: Ferritin (ng/mL) at three time points: Before the administration of intravenous ferric carboxymaltose (FCM), At the time of inclusion on the surgical waiting list, 30 days after surgery. And to compare the incidence of postoperative complications between patients who received FC and those who did not.
Analyze levels of transferrine
时间窗: From Jan 2019 to Dec 2022
To analyze the levels of: Transferrin (mg/dL) at three time points: Before the administration of intravenous ferric carboxymaltose (FCM), At the time of inclusion on the surgical waiting list, 30 days after surgery. And to compare the incidence of postoperative complications between patients who received FC and those who did not.
Analyze levels of transferrine saturation
时间窗: From Jan 2019 to Dec 2022
To analyze the levels of: Transferrin saturation (%) at three time points: Before the administration of intravenous ferric carboxymaltose (FCM), At the time of inclusion on the surgical waiting list, 30 days after surgery. And to compare the incidence of postoperative complications between patients who received FC and those who did not.
次要结局
- Compare ferric carboxymaltose vs control (other)(from january 2019 to decembre 2022)
研究者
Francisco Javier García Sánchez
PhD. MD. Surgical Prehabilitation Unit Coordinator
Hospital Universitario Infanta Cristina