Effect of Preoperative Intravenous Ferric Carboxymaltose on Postoperative Transfusion Reduction in Iron Deficiency Anemia Patients Scheduled for Clipping Surgery for Unruptured Intracranial Aneurysms: The PICASA Trial - A Single Center, Single-Blind Randomized Clinical Trial.

OBJECTIVE

This study aimed to evaluate the efficacy of preoperative ferric carboxymaltose (FCM) in reducing red blood cell transfusion (RBCT) in patients with iron deficiency anemia (IDA) undergoing microsurgical clipping of unruptured intracranial aneurysms (UIAs).

BACKGROUND

The impact of correcting preoperative anemia, a known predictor of RBCT, has been understudied in neurosurgical procedures.

METHODS

This single-blind, randomized controlled trial (RCT) included patients with IDA scheduled for microsurgical clipping of UIAs. Participants were randomized to receive either preoperative FCM, administered as intravenous FCM 4 weeks before surgery, or standard care without intervention (control group). The primary outcome was the incidence of RBCT. Secondary outcomes included postoperative clinical outcomes, adverse events related to FCM, and changes in hemoglobin (Hb), serum iron, ferritin, and transferrin saturation.

RESULTS

A total of 31 patients were randomized (17 in the FCM group and 14 in the control group). In the FCM group, Hb levels increased significantly by the day before surgery (p = 0.023), and no patients required RBCT, compared to 57.1% of patients in the control group (p < 0.001). Multivariate analysis identified FCM administration as the only independent factor significantly associated with reduced RBCT (OR 0.03, 95% CI 0-0.28, p < 0.001). In the inter-group analysis, Hb (p = 0.011) and ferritin (p < 0.001) levels were significantly higher in the FCM group throughout the observation period. No FCM-related adverse events were reported.

CONCLUSION

Preoperative FCM administration significantly reduced the need for perioperative RBCT and improved anemia-related biomarkers in patients with IDA undergoing clipping for UIAs, with no adverse events reported.

REGISTRATION: Clinical Trials under ID NCT04616092.