Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia

NCT06948864 | Completed FDA Drug

• 1 other identifier: ACT 04/22
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  From Jan 2019 to Dec 2022

Secondary Outcomes (14)

• Compare ferric carboxymaltose vs control (other)

  from january 2019 to decembre 2022

• Compare ferric carboxymaltose vs control (other)

  from january 2019 to decembre 2022

• Compare ferric carboxymaltose vs control (other)

  from january 2019 to decembre 2022

• Compare ferric carboxymaltose vs control (other)

  from january 2019 to decembre 2022

• Compare ferric carboxymaltose vs control (other)

  from january 2019 to decembre 2022

Study Arms (2)

Control (Not surgical prehabilitation)

This group received the standard preoperative patient assessment without going through a prehabilitation unit or undergoing any type of intervention. They did not receive this intervention because the surgical prehabilitation consultation had not yet been implemented at the hospital.

Interventional group (Surgical prehabilitation)

This group received standardized care and assessments in a surgical prehabilitation consultation, including preoperative blood tests, correction of conditions such as anemia (including intravenous iron), and the necessary supplementation to optimize the patients.

Drug: Ferric Carboxymaltose (FCM)

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

Also known as: infusion

Interventional group (Surgical prehabilitation)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Patients with hypersensitivity to FC, or any of its excipients. • Patients with active bleeding

Sponsors & Collaborators

• Hospital Universitario Infanta Cristina: lead

Study Sites (1)

Hospital Universitario Infanta Cristina

Parla, Madrid, 28981, Spain

Location

Related Publications (13)

• Bisbe Vives E. [Treatment of preoperative anemia in major orthopedic surgery]. Rev Esp Anestesiol Reanim. 2015 Jun;62 Suppl 1:52-6. doi: 10.1016/S0034-9356(15)30008-6. Spanish.

  PMID: 26320345 BACKGROUND

• Schack A, Berkfors AA, Ekeloef S, Gogenur I, Burcharth J. The Effect of Perioperative Iron Therapy in Acute Major Non-cardiac Surgery on Allogenic Blood Transfusion and Postoperative Haemoglobin Levels: A Systematic Review and Meta-analysis. World J Surg. 2019 Jul;43(7):1677-1691. doi: 10.1007/s00268-019-04971-7.

  PMID: 30824959 BACKGROUND

• Munoz M, Aragon S, Ballesteros M, Bisbe-Vives E, Jerico C, Llamas-Sillero P, Meijide-Miguez HM, Rayo-Martin E, Rodriguez-Suarez MJ. Executive summary of the consensus document on the management of perioperative anemia in Spain. Rev Clin Esp (Barc). 2024 Apr;224(4):225-232. doi: 10.1016/j.rceng.2024.02.012. Epub 2024 Feb 27.

  PMID: 38423382 BACKGROUND

• Calleja JL, Delgado S, del Val A, Hervas A, Larraona JL, Teran A, Cucala M, Mearin F; Colon Cancer Study Group. Ferric carboxymaltose reduces transfusions and hospital stay in patients with colon cancer and anemia. Int J Colorectal Dis. 2016 Mar;31(3):543-51. doi: 10.1007/s00384-015-2461-x. Epub 2015 Dec 22.

  PMID: 26694926 BACKGROUND

• Froessler B, Palm P, Weber I, Hodyl NA, Singh R, Murphy EM. The Important Role for Intravenous Iron in Perioperative Patient Blood Management in Major Abdominal Surgery: A Randomized Controlled Trial. Ann Surg. 2018 Feb;267(2):e39-e40. doi: 10.1097/SLA.0000000000002055. No abstract available.

  PMID: 29300713 BACKGROUND

• Garcia Erce JA, Altes A, Lopez Rubio M, Remacha AF; en representacion del Grupo Espanol de Eritropatologia de la Sociedad Espanola de Hematologia y Hemoterapia; Otros componentes del Grupo Espanol de Eritropatologia de la Sociedad Espanola de Hematologia y Hemoterapia. Management of iron deficiency in various clinical conditions and the role of intravenous iron: Recommendations of the Spanish Erythropathology Group of the Spanish Society of Haematology and Haemotherapy. Rev Clin Esp (Barc). 2020 Jan-Feb;220(1):31-42. doi: 10.1016/j.rce.2019.09.004. Epub 2019 Nov 27. English, Spanish.

  PMID: 31783987 BACKGROUND

• Laso-Morales M, Jerico C, Gomez-Ramirez S, Castellvi J, Viso L, Roig-Martinez I, Pontes C, Munoz M. Preoperative management of colorectal cancer-induced iron deficiency anemia in clinical practice: data from a large observational cohort. Transfusion. 2017 Dec;57(12):3040-3048. doi: 10.1111/trf.14278. Epub 2017 Aug 21.

  PMID: 28833205 BACKGROUND

• Munoz M, Acheson AG, Bisbe E, Butcher A, Gomez-Ramirez S, Khalafallah AA, Kehlet H, Kietaibl S, Liumbruno GM, Meybohm P, Rao Baikady R, Shander A, So-Osman C, Spahn DR, Klein AA. An international consensus statement on the management of postoperative anaemia after major surgical procedures. Anaesthesia. 2018 Nov;73(11):1418-1431. doi: 10.1111/anae.14358. Epub 2018 Jul 31.

  PMID: 30062700 BACKGROUND

• Savy M, Edmond K, Fine PE, Hall A, Hennig BJ, Moore SE, Mulholland K, Schaible U, Prentice AM. Landscape analysis of interactions between nutrition and vaccine responses in children. J Nutr. 2009 Nov;139(11):2154S-218S. doi: 10.3945/jn.109.105312. Epub 2009 Sep 30.

  PMID: 19793845 BACKGROUND

• Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9.

  PMID: 30025745 BACKGROUND

• Hu WH, Cajas-Monson LC, Eisenstein S, Parry L, Cosman B, Ramamoorthy S. Preoperative malnutrition assessments as predictors of postoperative mortality and morbidity in colorectal cancer: an analysis of ACS-NSQIP. Nutr J. 2015 Sep 7;14:91. doi: 10.1186/s12937-015-0081-5.

  PMID: 26345703 BACKGROUND

• Nicholls G, Mehta R, McVeagh K, Egan M. The Effects of Intravenous Iron Infusion on Preoperative Hemoglobin Concentration in Iron Deficiency Anemia: Retrospective Observational Study. Interact J Med Res. 2022 Feb 3;11(1):e31082. doi: 10.2196/31082.

  PMID: 35113024 BACKGROUND

• Mudarra-Garcia N, Roque-Rojas F, Izquierdo-Izquierdo V, Garcia-Sanchez FJ. Prehabilitation in Major Surgery: An Evaluation of Cost Savings in a Tertiary Hospital. J Clin Med. 2025 Apr 3;14(7):2460. doi: 10.3390/jcm14072460.

  PMID: 40217909 BACKGROUND

MeSH Terms

Conditions

Anemia; Infections

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. MD. Surgical Prehabilitation Unit Coordinator

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 29, 2025
• Study Start: January 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2024
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: End date: May 2025
• Access Criteria: Open Access

Locations

ES (1)