Preemptive intravenous iron therapy versus autologous whole blood therapy for early postoperative hemoglobin level in patients undergoing bimaxillary orthognathic surgery: a prospective randomized noninferiority trial
BMC oral health. 2021;21(1):16
BACKGROUND Previous studies have reported the efficacy and safety of intravenous (IV) iron therapy during the perioperative period as an alternative and adjunct to allogeneic blood transfusion. Preemptive IV iron therapy provides noninferior hemoglobin levels on postoperative day (POD) 1 compared to autologous whole blood therapy (AWBT) in healthy patients who had undergone bimaxillary orthognathic surgery. METHODS This was a prospective, patient-randomized, noninferiority trial. After excluding 2 patients, 64 patients were divided into two groups: the IV iron therapy group (patients received IV iron infusion 4 weeks before surgery; n = 32) and the AWBT group (2 units of autologous whole blood were collected 4 and 2 weeks before surgery; n = 32). The primary outcome was hemoglobin level on POD 1 and the prespecified noninferiority limit was - 1 g/dL. RESULTS Baseline data were comparable, including hemoglobin and iron levels, between the two groups. Immediately before surgery, the levels of hemoglobin, iron, and ferritin were higher in the IV iron group than in the AWBT group. The mean treatment difference (iron group-whole blood group) in hemoglobin level on POD 1 between the two groups was 0.09 (95% CI = - 0.83 to 1.0). As the lower limit of the 95% CI (- 0.83) was higher than the prespecified noninferiority margin (δ = - 1), noninferiority was established. On POD 2, the hemoglobin level became lower in the iron group, which eventually led to greater requirement of allogeneic blood transfusion compared to the whole blood group. However, the iron group did not require allogeneic blood transfusion during or early after surgery, and the whole blood group showed continuously higher incidence of overt iron deficiency compared to the iron group. CONCLUSION As collection of autologous whole blood caused overt iron loss and anemia before surgery and intraoperative transfusion of whole blood was not able to prevent the occurrence of persistent iron deficiency after surgery, IV iron therapy was found to have potential benefits for iron homeostasis and subsequent erythropoiesis in healthy patients early after bimaxillary orthognathic surgery. TRIAL REGISTRATION Clinical Research Information Service, Republic of Korea, approval number: KCT0003680 on March 27, 2019. https://cris.nih.go.kr/cris/search/search_result_st01_kren.jsp?seq=15769&sLeft=2<ype=my&rtype=my .
The effect of recombinant human erythropoietin on postoperative anemia in orthognathic patients Chinese
Shanghai Kou Qiang Yi Xue [Shanghai Journal of Stomatology]. 2004;13((4):):249-51.
PURPOSE To observe the effect of rhEPO on postoperative anemia in orthognathic patients. METHODS 31 patients had 500-1200 ml blood loss during orthognathic operation, who were divided into two groups randomly, the experiment group and the control group. The patients in the experiment group received rhEPO 6000IU subcutaneously for 3 times in a week and Ferrost sulfatis Et vitamini-medtech 1 tablet per day via oral administration for 12 days after operation, while the patients in the control group only received the same dose of Ferrost sulfatis Et vitamini-medtech. The loss of blood of the patients during operation were estimated and recorded. Their Hb and Hct were mensured before operation, and in the first, third, seventh-twelfth day after operation. RESULTS In the twelfth day after operation, the Hb and Hct of the patients in the experiment group had a significantly higher increase than that in the control group (P<0. 05). CONCLUSIONS rhEPO combined Ferrost sulfatis Et vitamini-medtech are suitable to apply in orthognathic patients with anemia after operation, which may effectively accelerate the recovery of their anemia, and avoid transfusion of blood.
The use of recombinant erythropoietin in the reduction of blood transfusion rates in craniosynostosis repair in infants and children
Plastic & Reconstructive Surgery. 2002;109((7):):2190-6.
The vast majority of infants and children undergoing craniosynostosis correction receive a blood transfusion. The risks of blood transfusion include, but are not limited to, acute hemolytic reactions (approximately 1 of 250,000), human immunodeficiency virus (approximately 1 of 200,000), hepatitis B and C (approximately 1 of 30,000 each), and transfusion-related lung injuries (approximately 1 of 5000). This prospective, single-blinded, randomized study was undertaken to examine the safety and efficacy of preoperative single weekly dosing with erythropoietin (epoetin alfa) in reducing the rate of transfusion in infants and small children undergoing craniosynostosis repair. A total of 29 patients (<8 years) undergoing craniosynostosis repair were randomized into two groups: one received preoperative erythropoietin (600 U/kg) weekly for 3 weeks, and the other served as a control. All caregivers responsible for blood transfusions were blinded, and strict criteria for transfusion were established. A pediatric hematologist monitored both groups, and all patients received supplemental iron (4 mg/kg). Fourteen patients were randomized to receive erythropoietin, and eight of these 14 patients (57 percent) required transfusion (mean age, 17 months; mean weight, 10.1 kg). Of the six patients not requiring transfusion, three were younger than 12 months old (mean, 6 months). Fourteen of 15 patients (93 percent) in the control group (mean age, 13 months; mean weight, 9.3 kg) required a blood transfusion during the study. The only control patient not requiring transfusion was the eldest (5 years old). The difference between the two groups was statistically significant (Fisher's exact test = 0.03). The control group showed no change in hemoglobin levels from baseline to preoperative levels, but the erythropoietin group increased their average hemoglobin levels from 12.1 to 13.1 g/dl. There were no adverse effects noted among children receiving erythropoietin, nor were there any surgical complications. The authors conclude that the preoperative administration of erythropoietin significantly raised hemoglobin levels and reduced the need for a blood transfusion with craniosynostosis correction. More suggestions are made that may further reduce the need for blood transfusions, and a cost-benefit analysis is discussed.
Autologous blood transfusion in oral and maxillofacial surgery patients with the use of erythropoietin
Journal of Maxillofacial Surgery. 2001;29((2)):118-125.
Background: Autologous blood transfusion presents few infectious or immunologic side effects. The aim of the present study was to determine the impact of autologous blood transfusion with or without recombinant human erythropoietin (rHuEPO) in patients who underwent elective maxillofacial operations. Material: Seventy eight consecutive patients (29 men and 49 women) underwent elective maxillofacial operations during the years 1990-95. Study design and Methods: The patients were randomly assigned to three groups: In group 1, 30 patients preoperatively underwent autologous blood predonation with intravenous injection of erythropoietin 600 IU/kg after each blood predonation and autologous blood transfusion intraoperatively; in group 2, 28 patients underwent the same procedure without erythropoietin and in group 3, 20 patients underwent homologous transfusion serving as control group. All patients received ferrous sulphate daily by mouth, preoperatively until one week postoperatively. Results: Group 1 patients showed higher levels of haematocrit, haemoglobin and red blood cell count pre- and postoperatively than the group 2 patients. It was also shown that the use of rHuEPO contributed to an improvement of the blood parameters of the patients in the group 1 compared with those of the patients in groups 2 and 3. Copyright 2001 European Association for Cranio-Maxillofacial Surgery.