NCT06948864

Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia

Evaluation of the Role of Preoperative Intravenous Iron in Patients Undergoing Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 152 (actual)
• Sponsor: Hospital Universitario Infanta Cristina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose (FCM)	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

Timeline

• Start date: 2020-01-01
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2025-04-29
• Last updated: 2025-05-02

Locations

1 site across 1 country: Spain

Regulatory

• FDA-regulated drug study