Clinical trial NCT06948864: Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia
Official title: Evaluation of the Role of Preoperative Intravenous Iron in Patients Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Anemia (Iron-Loading)
Perioperative Bleeding
Infection Prevention
Readmission, Hospital
Surgical Complication
Length of Hospital Stay
Iron Deficiency Anemia Treatment
Prehabilitation
Keywords: infection
anemia
length of stay
prehabilitation
Lead sponsor: Hospital Universitario Infanta Cristina
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises patients listed for major oncologic surgeries-such as nephrectomy, mastectomy, colon resection, or hysterectomy-which require general anesthesia and are associated with a high risk of perioperative morbidity and mortality

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analyze levels of Hemoglobine
timeFrame: From Jan 2019 to Dec 2022
measure: Analyze levels of ferritin
timeFrame: From Jan 2019 to Dec 2022
measure: Analyze levels of transferrine
timeFrame: From Jan 2019 to Dec 2022
measure: Analyze levels of transferrine saturation
timeFrame: From Jan 2019 to Dec 2022
Secondary outcomes:
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
measure: Compare ferric carboxymaltose vs control (other)
timeFrame: from january 2019 to decembre 2022
Other outcomes:
Locations:
city: Parla
country: Spain
facility: Hospital Universitario Infanta Cristina
state: Madrid
Study officials:
References:
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