Table 3Characteristics of Included Primary Clinical Studies

Study citation, country, funding sourceStudy design and objectivePopulation characteristicsIntervention and comparator(s)Clinical outcomes, length of follow-up
Randomized Controlled Trials
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:
  • Incidence of anemia
  • Hemoglobin level at admission
  • Length of stay
  • Post-operative complications
  • Adverse events
  • Mortality
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:
  • Change in full blood count and anemia panel
  • Adverse events
  • Complications
  • Mortality
  • Health-related QoL
Follow-up: 30 days for complications and mortality outcomes
Non-randomized Studies
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:
  • 30 days for complications
  • 30 to 90 days for days alive and out of hospital
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:
  • Incidence of transfusion
  • Average unit of blood transfused
  • Hospital length of stay
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:
  • Improved hemoglobin levels
  • Likelihood of transfusion
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:
  • Number of blood transfusions
  • In-hospital mortality
  • Infections
  • Adverse events
  • Complications
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:
  • Transfusion rate
  • Change in hemoglobin level
  • IV iron-related adverse event
  • In-hospital mortality
  • Hospital length of stay
Follow-up: 21-day postoperative follow-up for hemoglobin level analysis

IV = intravenous; kg = kilogram; mg = milligram; ml = milliliter; NA = not applicable; NR = not reported; QoL = quality of life; RCT = randomized controlled trial; SD = standard deviation; TAVI = transcatheter aortic valve implementation.

Note: This table has not been copy-edited.

From: Intravenous Iron Preparations for Patients Undergoing Elective Surgery: A 2022 Update

Cover of Intravenous Iron Preparations for Patients Undergoing Elective Surgery: A 2022 Update
Intravenous Iron Preparations for Patients Undergoing Elective Surgery: A 2022 Update: Rapid Review [Internet].
Hill S, Severn M; Authors.
Copyright © 2022 Canadian Agency for Drugs and Technologies in Health.

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