2021 ISAKOS Biennial Congress Paper
Efficacy And Safety Of Intravenous Ferric Carboxymaltose In Patients With Postoperative Anemia Following Same-Day Bilateral Total Knee Arthroplasty: A Randomized Controlled Trial
Man-Soo Kim, MD, PhD, Seoul KOREA, REPUBLIC OF
Yong Gyu Sung, MD, Seoul KOREA, REPUBLIC OF
Dong-Chul Park, MD, Seoul, South Korea KOREA, REPUBLIC OF
Jae Jung Kim, MD, Seoul KOREA, REPUBLIC OF
Yong In, MD, PhD, Seoul KOREA, REPUBLIC OF
Seoul St. Mary's Hospital, Seoul, Seoul, KOREA, REPUBLIC OF
FDA Status Cleared
Summary
In patients with postoperative anemia after same-day bilateral TKA, IV FCM infusion significantly improved Hb response 2 weeks after surgery without severe adverse events compared to placebo.
Abstract
Introduction
No prior randomized controlled trial has evaluated the efficacy and safety of intravenous (IV) ferric carboxymaltose (FCM) in treatment of postoperative anemia in patients undergoing same-day bilateral total knee arthroplasty (TKA). The purpose of this study was to evaluate the efficacy and safety of IV FCM to treat acute postoperative anemia following same-day bilateral TKA.
Methods
A total of 118 patients who underwent same-day bilateral TKA and had postoperative hemoglobin (Hb) level less than 10g/d by the third postoperative day were randomly assigned to one of two groups: FCM group (FCM infusion, 58 patients) and Control group (placebo with normal saline, 60 patients). Blood transfusion was performed when postoperative Hb level was <7 g/dL. The primary endpoint was number of responders with an Hb increase of 2 or more points (from baseline) by the second postoperative week. The secondary endpoints were Hb level, iron metabolism variables, number of patients requiring blood transfusion, quality of life (QOL) scale and Brief Pain Inventory (BPI) scores at 2 weeks, 6 weeks, and 3 months after surgery. Adverse events were also evaluated in both groups.
Results
Two weeks after surgery, the FCM group had more Hb responders than did the Control group (62.1 % vs. 31.6 %, p <0.001). The Hb level was significantly higher in the FCM group at 2 weeks, 6 weeks, and 12 weeks after surgery (all p < 0.05). Ferritin, iron, and transferrin saturation levels were significantly higher in the FCM group from 2 weeks postoperatively to 3 months postoperatively (all p < 0.05). However, there was no difference in transfusion rate after surgery (p > 0.05). The frequency of adverse events was not significantly different (p > 0.05).
Conclusion
In patients with postoperative anemia after same-day bilateral TKA, IV FCM infusion significantly improved Hb response 2 weeks after surgery without severe adverse events compared to placebo.