Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia

Hospital Universitario Infanta Cristina

Status: Completed

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

Treatments: Drug: Ferric Carboxymaltose (FCM)

Study type: Observational

Funder types: Other

Identifiers

NCT06948864

ACT 04/22

Details and patient eligibility

About

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).

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

152 participants in 2 patient groups

Control (Not surgical prehabilitation)

Description:

This group received the standard preoperative patient assessment without going through a prehabilitation unit or undergoing any type of intervention. They did not receive this intervention because the surgical prehabilitation consultation had not yet been implemented at the hospital.

Interventional group (Surgical prehabilitation)

Description:

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.

Treatment:

Drug: Ferric Carboxymaltose (FCM)