Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Preoperative Intravenous Iron Isomaltoside in Colorectal Cancer Surgical Patients With Iron Deficiency Anaemia Compared to Standard Care: a Pilot Randomized Controlled Trial

Conditions
-----------------
Anemia, Iron-Deficiency, Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: iron isomaltoside(Monofer®)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment arm<br>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 | Drug: iron isomaltoside(Monofer®)<br>* intravenous iron isomaltoside<br>|
| No Intervention: Control arm<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Units of red blood cells transfused in perioperative period | Units of red blood cells transfused from diagnosis to discharge | 3 weeks to 12 weeks | 
| Duration of hospital stay (days) |  | 1 days up to 1 month | 
| 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 | recorded and graded according to Clavien Classification of Surgical Complications | up to post op day 30 | 
| Days (alive and) at home within 30 days of surgery (DAH30) |  | up to post op day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient blood management