Skip to main content
OpenTrials
Completed

NCT Number: NCT06948864

Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anemia Anemia (Iron-Loading) Hematologic Diseases Hemic and Lymphatic Diseases Infection Prevention Infections Iron Deficiency Anemia Treatment Length of Hospital Stay Perioperative Bleeding Prehabilitation Readmission, Hospital Surgical Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Infanta Cristina

Parla, Madrid, 28981, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: infusion

Primary outcomes

  1. Analyze levels of Hemoglobine

    Time frame: From Jan 2019 to Dec 2022

    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.

  2. Analyze levels of ferritin

    Time frame: From Jan 2019 to Dec 2022

    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.

  3. Analyze levels of transferrine

    Time frame: From Jan 2019 to Dec 2022

    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.

  4. Analyze levels of transferrine saturation

    Time frame: From Jan 2019 to Dec 2022

    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.

Secondary outcomes

  1. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Hospital length of stay (in days)

  2. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    ICU admission (yes/no)

  3. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    ICU length of stay (in days)

  4. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Need for hospital readmission (yes/no)

  5. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Need for blood transfusion (yes/no)

  6. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Surgical wound infection (Yes/no)

  7. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Complications (yes/no)

  8. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Sepsis (yes/no)

  9. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Pleural effusion (yes/no)

  10. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Respiratory infection (yes/no)

  11. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Abdominal colection (yes/no)

  12. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Paralytic ileum (yes/no)

  13. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Bleeding (yes/no)

  14. Compare ferric carboxymaltose vs control (other)

    Time frame: from january 2019 to decembre 2022

    To compare between the groups (ferric carboxymaltose vs. control):

    Urinary tract infection (yes/no)

Sponsors and collaborators

Lead sponsor

Hospital Universitario Infanta Cristina

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2024
First posted
Apr 29, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.