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Evaluate the Outcomes of Ferric Carboxymaltose in Patients With Perioperative Anemia

NCT06948864 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 152

Last updated 2025-05-02

No results posted yet for this study

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

Interventions

DRUG

Ferric Carboxymaltose (FCM)

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

Sponsors & Collaborators

  • Hospital Universitario Infanta Cristina

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2022-12-31
Completion
2024-12-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06948864 on ClinicalTrials.gov