AnemiaNCT06948864
Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia
An observational study of Anemia and Anemia (Iron-Loading), run by Hospital Universitario Infanta Cristina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Anemia (Iron-Loading), Perioperative Bleeding
- What is being tested?
- Ferric Carboxymaltose (FCM)
- Type of treatment
- Injection or infusion
- How many people
- 152 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2020to 31 Dec 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients with hypersensitivity to FC, or any of its excipients. • Patients with active bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Role of Preoperative Intravenous Iron in Patients Undergoing Surgery
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).
Read the 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
- Being tested
- Ferric Carboxymaltose (FCM)
- Keywords
- infection, anemia, length of stay, prehabilitation
- Medical subject headings
- Anemia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose (FCM)Drug
Also called infusion
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ferric Carboxymaltose (FCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Jan 2019 to Dec 2022
Secondary outcomes (14)
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Hospital length of stay (in days)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
ICU admission (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
ICU length of stay (in days)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Need for hospital readmission (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Need for blood transfusion (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Surgical wound infection (Yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Complications (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Sepsis (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Pleural effusion (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Respiratory infection (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Abdominal colection (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Paralytic ileum (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Bleeding (yes/no)
Measured: from january 2019 to decembre 2022
Compare ferric carboxymaltose vs control (other)
To compare between the groups (ferric carboxymaltose vs. control):
Urinary tract infection (yes/no)
Measured: from january 2019 to decembre 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Infanta Cristina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier García Sánchez, Hospital Universitario Infanta Cristina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948864
- Sponsor's protocol ID
- ACT 04/22
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A manuscript for divulgating results.
Publications
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.
PubMed 26320345Schack 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.
PubMed 30824959Munoz 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.
PubMed 38423382Calleja 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.
PubMed 26694926Froessler 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.
PubMed 29300713Garcia 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.
PubMed 31783987Laso-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.
PubMed 28833205Munoz 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.
PubMed 30062700Savy 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.
PubMed 19793845Gillis 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.
PubMed 30025745Hu 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.
PubMed 26345703Nicholls 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.
PubMed 35113024Mudarra-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.
PubMed 40217909