CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 152 enrolled
Drug / intervention
Ferric Carboxymaltose (FCM)drug
Likely dose
Ferric Carboxymaltose (FCM) 13 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06948864
NCT06948864N/ACompleted

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

Hospital Universitario Infanta Cristina·observational·Posted Apr 29, 2025·Updated May 2, 2025

In Brief

An observational study evaluating Ferric Carboxymaltose (FCM) for Anemia and 8 related conditions. Completed, enrolled 152 participants across 1 site.

Detailed 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).

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 29, 2025
Enrollment StartJan 1, 2020
Primary CompletionDec 31, 2022
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 1.2 years ago

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