Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients

Phase 3

Completed

• Conditions: Colorectal Cancer; Anemia, Iron-Deficiency
• Interventions: Drug: iron isomaltoside(Monofer®)

• Registration Number: NCT03565354
• Lead Sponsor: Prince of Wales Hospital, Shatin, Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-21
• Study Start: 2018-07-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment arm	iron isomaltoside(Monofer®)	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

Primary Outcome Measures

Name	Time	Method
Preoperative change in serum ferritin (mcg/L)	3 weeks to 10 weeks	the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).
Preoperative change in hemoglobin concentration (g/dL)	3 weeks to 10 weeks	the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).

Secondary Outcome Measures

Name	Time	Method
Days (alive and) at home within 30 days of surgery (DAH30)	up to post op day 30
Units of red blood cells transfused in perioperative period	3 weeks to 12 weeks	Units of red blood cells transfused from diagnosis to discharge
Quality of recovery as measured by questionnaire (QoR-15(Chinese))	post op day 3
Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions	up to post op day 30
Rate of surgical complications	up to post op day 30	recorded and graded according to Clavien Classification of Surgical Complications
Duration of hospital stay (days)	1 days up to 1 month

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong