A Phase 3 interventional study of iron isomaltoside(Monofer®) in Anemia, Iron-Deficiency and Colorectal Cancer, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-20.
Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Phase 3, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 40 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Prince of Wales Hospital, Shatin, Hong Kong is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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®)
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.
intravenous iron isomaltoside
Preoperative change in hemoglobin concentration (g/dL)
the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).
Time frame: 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).
Time frame: 3 weeks to 10 weeks
Units of red blood cells transfused in perioperative period
Units of red blood cells transfused from diagnosis to discharge
Time frame: 3 weeks to 12 weeks
Duration of hospital stay (days)
Time frame: 1 days up to 1 month
Quality of recovery as measured by questionnaire (QoR-15(Chinese))
Time frame: post op day 3
Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions
Time frame: up to post op day 30
Rate of surgical complications
recorded and graded according to Clavien Classification of Surgical Complications
Time frame: up to post op day 30
Days (alive and) at home within 30 days of surgery (DAH30)
Time frame: up to post op day 30
Patient recruitment rate(%)
number of recruited patients divided by number of eligible patients x 100%
Time frame: through study completion, an average of 1 year
Number of patients recruited per month
Time frame: through study completion, an average of 1 year
Median waiting time to surgery (days)
Time frame: through study completion, an average of 1 year
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Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Prince of Wales Hospital, Shatin, Hong Kong