Innovative Method for Infectious Complications Reducing After Orthopedic Interventions Via Preventive Hemocorrection. Protocol for a Randomized Controlled Trial
Year: 2025
Type: article
Study design: Study Protocol
Abstract: Introduction. Septic complications following orthopedic procedures remain a pressing challenge in modern surgical practice, contributing significantly to patient morbidity, prolonged hospital stays, increased healthcare costs, and, in severe cases, long-term disability. One of the modifiable but often overlooked risk factors is preoperative anemia, which is frequently underdiagnosed and undertreated. Existing evidence indicates that allogeneic blood transfusions, commonly used to correct anemia, are independently associated with a higher risk of postoperative infections. This underscores the urgent need to explore alternative, safer strategies for perioperative management, particularly those targeting the correction of anemia prior to surgery. Aim. To evaluate the effectiveness of perioperative intravenous iron supplementation with ferric carboxymaltose in reducing the incidence of periprosthetic joint infections and improving clinical outcomes in patients undergoing elective orthopedic surgery. Methods. The IRON study is a prospective, single-center, randomized, open-label, controlled clinical trial. A total of 170 adult patients scheduled for elective orthopedic interventions will be enrolled and randomized to receive perioperative intravenous ferric carboxymaltose at a dose of 15 mg/kg (up to a maximum of 1000 mg). Primary endpoint. The incidence of periprosthetic joint infections within the postoperative follow-up period. Secondary endpoints. 28-day all-cause survival, duration of stay in the intensive care unit and in the hospital, achievement of target hemoglobin levels (≥120 g/L in women, ≥130 g/L in men), number of vasopressor-free days, reduction in the frequency and volume of intraoperative and postoperative blood transfusions, and decreased utilization of the Cell Salvage System. Expected Results: Although patient enrollment is ongoing, it is hypothesized that intravenous iron therapy will reduce the rate of infectious complications and the need for allogeneic transfusions, while improving postoperative recovery and hematologic parameters.
Source: Medicine and ecology
Institution: Astana Medical University
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4413194137