Anemia, Iron-Deficiency Perioperative Care
Conditions
Interventions
This is a randomized, controlled, double-blind clinical trial with two parallel arms. A total of 60 female patients, aged over 18 years, diagnosed with iron deficiency anemia and scheduled for electiv
s prescribing information. Control group: 30 patients will receive intravenous 0.9% saline solution (placebo), under the same conditions of volume, infusion time, monitoring, and observation as the in
Sponsors
Universidade Federal do Rio de Janeiro
Universidade Federal do Rio de Janeiro
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: The patients studied will be female, over 18 years of age, with an indication for elective hysterectomy with or without oophorectomy and/or annexectomy and myomectomy at HUCFF/UFRJ. Patients with anemia due to absolute or functional iron deficiency, Hg < 12g/dl; ferritin < 30 mcg/L or 30-300 mcg/L with transferrin saturation < 20%
Exclusion criteria
Exclusion criteria: Individuals under 18 years of age. Patients who have received treatment with packed red blood cells before entering the protocol within the last 3 months. Patients undergoing urgent/emergency surgery. Patients with a formal contraindication to the use of intravenous iron, such as known hypersensitivity. Conditions that lead to secondary iron overload, such as: hereditary hemolytic anemias, myelodysplastic syndrome, Fanconi anemia. Anemias of other non-iron deficiency etiologies. Septic patients and pregnant women in the first trimester. Patients whose surgery was canceled or not performed. Patients participating in another clinical trial. Patients with dialysis-dependent renal failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the impact of preoperative intravenous ferric hydroxide saccharate infusion on the requirement for allogeneic red blood cell transfusion in patients undergoing elective gynecological surgery at HUCFF/UFRJ. Transfusion requirement will be assessed by recording the proportion of patients receiving transfusion and the number of red blood cell units transfused per patient during the perioperative period. A reduction in transfusion rate and in the mean number of transfused units is expected in the intervention group compared to the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Hemoglobin: Evaluate hemoglobin levels in the preoperative period, after the intervention, and in the postoperative period (48–72 hours). Values will be obtained through serial laboratory tests and expressed in g/dL. Higher hemoglobin levels are expected in the group receiving intravenous iron; Postoperative infection: Evaluate the incidence of postoperative infection. This will be assessed through clinical records and the need for medical intervention (antibiotic therapy, drainage, or prolonged hospitalization). A lower incidence of infection is expected in the intervention group; Acute kidney injury (AKI): Evaluate the occurrence of acute kidney injury in the postoperative period. It will be defined according to KDIGO criteria, based on changes in serum creatinine. A lower incidence is expected in the intervention group; Length of hospital stay: Evaluate the duration of hospital stay. It will be measured in days, from admission to hospital discharge. A reduction in length of stay is expected in the intervention group; Mortality: Evaluate mortality within 30 days after the surgical procedure. This will be verified through medical records and clinical follow-up. Lower mortality is expected in the intervention group; Hospital cost: Evaluate the estimated cost of hospitalization. It will be calculated based on standardized values from the Sistema Único de Saúde (SUS), including costs of transfusions, hospital stay, and complications. A reduction in costs is expected in the intervention group. | — |
Countries
BR
Contacts
Public ContactMarcelo Zylberberg
Universidade Federal do Rio de Janeiro
Outcome results
None listed