Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia

Completed

• Conditions: Anemia; Anemia (Iron-Loading); Perioperative Bleeding; Infection Prevention; Readmission, Hospital; Surgical Complication; Length of Hospital Stay; Iron Deficiency Anemia Treatment; Prehabilitation
• Interventions: Drug: Ferric Carboxymaltose (FCM)

• Registration Number: NCT06948864
• Lead Sponsor: Hospital Universitario Infanta Cristina

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-28
• Study First Posted: 2025-04-29
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• 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

Exclusion Criteria

• Patients with hypersensitivity to FC, or any of its excipients. • Patients with active bleeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Interventional group (Surgical prehabilitation)	Ferric Carboxymaltose (FCM)	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.

Primary Outcome Measures

Name	Time	Method
Analyze levels of transferrine	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 Hemoglobine	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	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 saturation	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.

Secondary Outcome Measures

Name	Time	Method
Compare ferric carboxymaltose vs control (other)	from january 2019 to decembre 2022	To compare between the groups (ferric carboxymaltose vs. control): Urinary tract infection (yes/no)

Trial Locations

Locations (1)

Hospital Universitario Infanta Cristina; 🇪🇸 Parla, Madrid, Spain