Randomized Controlled Trials
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Fung et al. (2022)22 Hong Kong Funding source: No funding | Study design: RCT Objective: To determine the effects of IV iron isomaltoside for iron deficiency treatment in individuals scheduled for colorectal surgery | Eligibility criteria: Adults diagnosed with colorectal cancer listed for elective curative tumour resection operation with anemia or iron deficiency Number of participants: 40 (20 in iron therapy group and 20 in control group) Mean age (SD): 68.4 (6.8) iron therapy group; 69.8 (12.6) control group Number of males (%): 15 (75%) iron therapy group; 9 (45%) control group | Intervention (dose): IV iron isomaltoside (20 mg/kg up to 1,000 mg infused for 30 minutes) 3 weeks before surgery Comparator: No treatment | Outcomes:Changes in hemoglobin concentration Changes in ferritin concentration Blood transfusion during peri-operative period Surgical complications Post-operative length of stay Quality of recovery Follow-up: 30 days after surgery for quality of recovery measurement |
Kvaslerud et al. (2022)23 Norway Funding source: Pharmacosmos provided medication and the study grant | Study design: RCT Objective: To evaluate whether IV iron could provide benefits for iron deficient patients with severe aortic stenosis after TAVI | Eligibility criteria: Patients who had severe aortic stenosis and iron deficiency Number of participants: 104 (51 received intervention and 53 received a placebo) Mean age, years (SD): 80 (7.8) intervention group; 79.2 (6.5) control group Number of males (%): 28 (55%) intervention group; 32 (60%) control group | Intervention (dose): IV ferric derisomaltose (20 mg/kg or maximum dose of 2,000 mg) Comparator: Placebo (IV saline solution) | Outcomes:6-minute walk distance Quality of life Follow-up: 3 months post-operative |
Shokri et al. (2022)24 Egypt Funding source: No funding | Study design: RCT Objective: To evaluate the effects of pre-operative IV iron use in patients undergoing elective coronary artery bypass grafting | Eligibility criteria: Patients aged 52 to 67 with anemia scheduled for elective coronary artery bypass grafting and eligible to receive IV iron Number of participants: 80 (40 received intervention and 40 received a placebo) Mean age, years (SD): 58.35 (4.44) intervention group; 60.8 (4.79) control group Number of female (%): 22 (55%) intervention group; 15 (37.5%) control group | Intervention (dose): IV ferric carboxymaltose (single dose of 1,000 mg) 7 days before surgery Comparator: Placebo (100 ml of saline solution) 7 days before surgery | Outcomes:Follow-up: 4 weeks post discharge |
Thin et al. (2021)25 Singapore Funding source: Khoo Pilot Award from Duke-NUS Medical School. Vifor Pharma provided the investigational product medication doses. | Study design: RCT Objective: To determine the feasibility to compare the pre-operative treatment of iron deficiency with IV iron therapy versus oral iron therapy in patients undergoing elective major abdominal surgery | Eligibility criteria: Patients adults aged 21 years and older with iron-deficiency anemia, scheduled for elective major abdominal surgery, presenting between one and 4 weeks of their planned surgery, and who can receive the study intervention at least 7 days before the date of surgery Number of participants: 26 (13 received intervention and 13 received a placebo) Mean age, years (SD): 59.2 (12.4) intervention group; 55.2 (23.3) control group Number of female (%): 10 (76.9%) intervention group; 8 (61.5%) control group | Intervention (dose): IV ferric carboxymaltose (single dose of 15 mg/kg up to 1,000 mg) Comparator (dose): Oral iron (ferrous fumarate 200 mg twice daily until 1 day before surgery) | Outcomes:Follow-up: 30 days for complications and mortality outcomes |
Non-randomized Studies
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Ploug et al. (2022)26 Denmark Funding source: Supported by grants from “The region of Southern Denmark”, “The University of Southern Denmark, SDU” and from Pharmacosmos. | Study design: Retrospective cohort study Objective: To investigate the efficacy of pre-operative IV iron treatment in everyday clinical practice in a series of consecutive iron deficient anemic patients undergoing elective surgery for colorectal cancer | Eligibility criteria: Patients undergoing colorectal cancer surgery and who were diagnosed with iron deficiency anemia at the time of the colorectal cancer diagnosis. Number of participants: 170 (122 received iron therapy and 48 did not receive iron therapy) Mean age, years (range): 75 (70 to 82) treatment group; 74.5 (63.5 to 82.5) no treatment group Number of female (%): 54 (44.3%) treatment group; 26 (54.2%) no treatment group | Intervention (dose): IV ferric derisomaltose (20 mg/kg) Comparator: No treatment |
Outcomes:
Change in hemoglobin concentration Peri-operative transfusion rate Postoperative complications Hospital length of stay Days alive and out of hospital
Follow-up:
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Abdullah et al. (2021)27 Singapore Funding source: Funded by department funds from the Department of Anaesthesiology, Singapore General Hospital | Study design: Retrospective cohort study Objective: To compare the incidence of blood transfusion and hospital length of stay between anemic patients who received IV iron pre-operatively to undergoing elective surgery versus standard care | Eligibility criteria: Patients who had undergone elective surgeries requiring general anesthesia or regional anesthesia, except for transplant, burns and cardiac surgery, and who were diagnosed with iron deficiency anemia and were prescribed pre-operative IV iron therapy Number of participants: 7696 (89 received IV iron therapy and 7607 received oral iron therapy) Mean age, years (SD): 55.2 (15.3) in IV iron therapy group; 58 (16.2) in oral iron therapy group Number of female (%): 68 (76.4%) in IV iron therapy group; 5483 (72.1%) in oral iron therapy group | Intervention (dose): IV ferric carboxymaltose (15 mg/kg up to 1,000 mg Comparator: Oral iron therapy (dose not specified) | Outcomes:Follow-up: NA (chart review) |
Evans et al. (2021)28 UK Funding source: NR | Study design: Retrospective cohort study Objective: To analyze data from patients undergoing elective cardiac surgery to assess the impact of intravenous iron on pre-operative hemoglobin and transfusion | Eligibility criteria: Patients with iron deficiency anemia at surgical pre-assessment were considered for intravenous iron as an outpatient Number of participants: 447 (75 were anemic and received treatment; 72 were anemic and did not receive treatment; and 300 were not anemic) Mean age, years (SD): 71 (11) in the treated anemic group; 72 (8) in the anemic untreated group; 68 (11) in the non-anemic group Number of male (%): 48 (64%) in the treated anemic group; 32 (44%) in the anemic untreated group; 228 (76%) in the non-anemic group | Intervention (dose): IV iron isomaltoside (20 mg/kg) Comparator: No treatment | Outcomes:Transfusion requirements Length of stay In-hospital mortality Follow-up: 30-day mortality |
Peel et al. (2021)29 Canada Funding Source: The University of Toronto Quality in Utilization, Education and Safety Research Program as part of a Canadian Blood Services Project Grant | Study design: Retrospective cohort study Objective: To determine optimal treatment strategies for using iron therapy for pre-operative anemia in adults undergoing cardiac surgery | Eligibility criteria: Patients with anemia schedules for a procedure with a high transfusion rate, all major high blood loss surgeries, and bleeding disorder or signed refusal of blood products Number of participants: 532 (84 IV iron therapy; 207 oral iron therapy; 71 epoetin therapy; 92 dual therapies; 78 no treatment) Mean age, years (SD): 68 (13) IV iron therapy; 67 (12) oral iron therapy; 71 (8) epoetin therapy; 70 (12) dual therapy; 68 (10) no treatment Number of female (%): 41 (48%) IV iron therapy; 77 (68%) oral therapy; 34 (48%) epoetin therapy; 53 (58%) dual therapy; 24 (31%) no treatment | Intervention (dose): IV iron sucrose (200 to 300 mg) Comparator: Oral iron (ferrous fumarate), epoetin alfa, no treatment | Outcomes:Follow-up: NA (chart review) |
Quarterman et al. (2021)30 UK Funding source: NR | Study design: Retrospective cohort study Objective: To evaluate outcomes of patients undergoing elective cardiac surgery who attended a pre-operative anemia clinic for the diagnosis and treatment of iron deficiency anemia | Eligibility criteria: Elective cardiac and aortic surgical patients with proven iron deficiency and anemia Number of participants: 2864 (190 received treatment; 581 did not receive treatment; 2093 not anemic) Mean age, years (range): 71 (63 to 77) received treatment; 73 (67 to 78) did not receive treatment; 69 (61 to 75) not anemic Number of female (%): 104 (54.7%) received treatment; 280 (48.2%) did not receive treatment; 409 (19.5%) not anemic | Intervention (dose): Iv iron isomaltoside (single dose of 1,000 mg or 20 mg/kg) Comparator: No treatment | Outcomes:Follow-up: NA (chart review) |
Triphaus et al. (2021)31 Germany Funding source: NR | Study design: Prospective cohort study Objective: To evaluate the outcomes of iron deficient anemic patients with and without iron supplementation compared to non-anemic patients | Eligibility criteria: Adults undergoing major surgery were screened for iron deficiency anemia between 2015 and 2018 and grouped based on anemia and treatment status Number of participants: 1728 (184 patients with iron deficiency anemia and received treatment; 55 patients without anemia but iron deficiency and received treatment; 461 with anemia and no treatment; 1028 without anemia and no treatment) Mean age, years (SD): 63.3 (16.1) iron deficient anemic who received treatment; 59.5 (15.7) not anemic but iron deficient and received treatment; 65.6 (14.2) anemic with no treatment; 63.6 (13.2) not anemic and no treatment Number of female (%): 73 (39.5%) iron deficient anemic who received treatment; 29 (52.7%) not anemic but iron deficient and received treatment; 111 (24.1%) anemic with no treatment; 307 (29.9%) not anemic and no treatment | Intervention (dose): IV ferric carboxymaltose (500 mg or 1,000 mg) Comparator: No treatment | Outcomes:Follow-up: 21-day postoperative follow-up for hemoglobin level analysis |