Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients

Prince of Wales Hospital

Status and phase: Completed; Phase 3

Conditions: Anemia, Iron-Deficiency; Colorectal Cancer

Treatments: Drug: iron isomaltoside(Monofer®)

Study type: Interventional

Funder types: Other

Identifiers

NCT03565354

NTEC-2018-0169

Details and patient eligibility

About

Iron deficiency anaemia is a common condition among colorectal surgical patient. Untreated anaemia would lead to increase in blood transfusion, surgical complications and mortality. Treatment with oral iron sulphate is poorly tolerated due to side effects. Intravenous iron supplement provides an alternative way to rapidly replace iron deficit during the preoperative period among surgical patients. Evidence is growing for its effect in rising hemoglobin level and reducing blood transfusion, at the same time supporting its safety profile.

The investigators plan for a single-centered, randomized controlled trial to examine the effect of intravenous iron compared to standard care in terms of hemoglobin level/serum ferritin increment, need for blood transfusion, duration of hospital stay, quality of recovery and surgical complication rate, as well as safety profile among colorectal cancer surgical patients in Hong Kong. The investigator propose the following pilot RCT for exploring the effect size and study process in conducting the above-mentioned large-scale RCT.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age >18 years old with written informed consent
• Anaemia defined as: hemoglobin concentration < 13g/dL (same cut-off for both male and female patients according to the International consensus statement on the perioperative management of anaemia and iron deficiency)2
• Laboratory test confirmed iron deficiency: serum ferritin <30mcg/L alone or serum ferritin 30-100mcg/L with TSAT < 20%

Exclusion criteria

• Pregnancy or lactation
• Other known causes of anaemia apart from iron deficiency: untreated B12/folate deficiency, hemolytic disease, hemoglobinopathy/thalassemia, chronic renal failure on dialysis
• Presence of iron overload (serum ferritin > 300g/dL or TSAT > 50%); known hemochromatosis
• Previous or ongoing iron replacement/use of erythropoietin within 12 weeks before recruitment
• Known hypersensitivity towards iron isomaltoside
• Significant liver function derangement (AST/ALP exceeding three times upper limit of normal range)
• Participation in another ongoing interventional clinical trial(s)
• Patients with less than 3 weeks waiting time to surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Treatment arm

Active Comparator group

Description:

intravenous iron isomaltose 3-10 weeks before operation date. The dose will be determined by the patient's body weight: \> 50kg: 1000mg; \<50kg: 20mg/kg body weight, to be infused over 30 minutes. 2 weeks after intravenous iron isomaltoside administration, blood test for hemoglobin level and iron profile would be repeated. Subjects with hemoglobin level less than 10g/dL will receive a second dose of intravenous iron isomaltoside. The second dose would be identical to the first dose

Treatment:

Drug: iron isomaltoside(Monofer®)

Control arm

No Intervention group

Description:

Patient randomized to the control arm will follow the standard perioperative care and the perioperative management they received will be identical to the treatment arm except no intravenous iron isomaltoside will be given.