A randomised trial evaluating the effect of intraoperative iron administration

Lee, Bora; Kim, E. J.; Song, Jaewoo; Jung, Young-Soo; Koo, Bon‐Nyeo

doi:10.1038/s41598-020-72827-5

Cited by 7 publications

(6 citation statements)

References 36 publications

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“…ferric derisomaltose after anaesthetic induction resulted in higher Hb levels and a significant increase in reticulocyte production index at 2 weeks postoperatively compared with placebo. 1022 This supports the results of an earlier study, which demonstrated that peri-operative i.v. iron isomaltoside infusion (1000 mg) resulted in significantly increased Hb levels and a lower incidence of anaemia in cardiac surgery patients at 1 month after surgery.…”

Section: Evidence Summarysupporting

confidence: 91%

Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care

Kietaibl

Ahmed

Afshari

et al. 2023

European Journal of Anaesthesiology

103

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BACKGROUND Management of peri-operative bleeding is complex and involves multiple assessment tools and strategies to ensure optimal patient care with the goal of reducing morbidity and mortality. These updated guidelines from the European Society of Anaesthesiology and Intensive Care (ESAIC) aim to provide an evidence-based set of recommendations for healthcare professionals to help ensure improved clinical management. DESIGN A systematic literature search from 2015 to 2021 of several electronic databases was performed without language restrictions. Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used to assess the methodological quality of the included studies and to formulate recommendations. A Delphi methodology was used to prepare a clinical practice guideline. RESULTS These searches identified 137 999 articles. All articles were assessed, and the existing 2017 guidelines were revised to incorporate new evidence. Sixteen recommendations derived from the systematic literature search, and four clinical guidances retained from previous ESAIC guidelines were formulated. Using the Delphi process on 253 sentences of guidance, strong consensus (>90% agreement) was achieved in 97% and consensus (75 to 90% agreement) in 3%. DISCUSSION Peri-operative bleeding management encompasses the patient's journey from the pre-operative state through the postoperative period. Along this journey, many features of the patient's pre-operative coagulation status, underlying comorbidities, general health and the procedures that they are undergoing need to be taken into account. Due to the many important aspects in peri-operative nontrauma bleeding management, guidance as to how best approach and treat each individual patient are key. Understanding which therapeutic approaches are most valuable at each timepoint can only enhance patient care, ensuring the best outcomes by reducing blood loss and, therefore, overall morbidity and mortality. CONCLUSION All healthcare professionals involved in the management of patients at risk for surgical bleeding should be aware of the current therapeutic options and approaches that are available to them. These guidelines aim to provide specific guidance for bleeding management in a variety of clinical situations.

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Section: Evidence Summarysupporting

confidence: 91%

Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care

Kietaibl

Ahmed

Afshari

et al. 2023

European Journal of Anaesthesiology

103

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“…Finally, we did not measure the long-term postoperative changes in hemoglobin, iron, and ferritin levels, such as those occurring over weeks to months. However, based on previously reported findings [ 30 , 43 ], sufficient amounts of iron and ferritin in patients with IV iron therapy may play roles in restoring appropriate hemoglobin levels postoperatively. However, our study is the first to perform a non-inferiority comparison of the effect of a novel IV iron drug (ferric carboxymaltose) and conventional blood salvage therapy (autologous whole blood donation) on the postoperative hemoglobin level in robust young patients undergoing bimaxillary orthognathic surgery.…”

Section: Resultsmentioning

confidence: 99%

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

et al. 2021

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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&ltype=my&rtype=my.

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Section: Discussionmentioning

confidence: 99%

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

Chae

Lee

Choi

et al. 2020

Preprint

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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, 2019https://cris.nih.go.kr/cris/search/search_result_st01_kren.jsp?seq=15769&sLeft=2&ltype=my&rtype=my

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A randomised trial evaluating the effect of intraoperative iron administration

Cited by 7 publications

References 36 publications

Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care

Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care

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

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

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