Anemia, Iron-Deficiency, Colorectal Cancer
Conditions
Keywords
Patient blood management
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.
Interventions
DRUGiron isomaltoside(Monofer®)
intravenous iron isomaltoside
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Units of red blood cells transfused in perioperative period | 3 weeks to 12 weeks | Units of red blood cells transfused from diagnosis to discharge |
| 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 |
| Days (alive and) at home within 30 days of surgery (DAH30) | up to post op day 30 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Median waiting time to surgery (days) | through study completion, an average of 1 year | — |
| Patient recruitment rate(%) | through study completion, an average of 1 year | number of recruited patients divided by number of eligible patients x 100% |
| Number of patients recruited per month | through study completion, an average of 1 year | — |
Countries
Hong Kong
Outcome results
None listed