Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia

Hospital Universitario Infanta Cristina152 enrolled

Overview

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).

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 Type

OBSERVATIONAL

Enrollment

152

Conditions

Anemia Anemia (Iron-Loading)Perioperative Bleeding Infection Prevention

Interventions

Ferric Carboxymaltose (FCM)DRUG

Patients in the intervention group underwent surgery from 2020 to end-2022 and were managed according to the surgery prehabilitation protocol. Once the surgeon has included the patient on the SWL, they were evaluated and followed up by the prehabilitation nurse (no more than 72 hours in the case of cancer patients) together with the study internist. The protocol at this preoperative stage consists of a comprehensive biopsychosocial assessment and an analysis of lab and nutritional parameters, which are optimized using targeted treatment. One of the lab parameters analyzed was Hb. Study patients with Hb \< 13 g/dL received 500 mg, 1000 mg, 1500 mg or 2000 mg FCM, depending on their levels of Hb, ferritin, transferrin saturation index, and weight. The lab test was repeated immediately before surgery or 30 days after administration of FCM in order to determine whether Hb levels had improved with FCM therapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Analyze levels of Hemoglobine

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.

Time frame: From Jan 2019 to Dec 2022

Analyze levels of ferritin

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.

Time frame: From Jan 2019 to Dec 2022

Analyze levels of transferrine

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.

Time frame: From Jan 2019 to Dec 2022

Analyze levels of transferrine saturation

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.

Time frame: From Jan 2019 to Dec 2022

Secondary Outcomes

Compare ferric carboxymaltose vs control (other)

To compare between the groups (ferric carboxymaltose vs. control): Hospital length of stay (in days)