Clinical trial NCT03565354: Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia, Iron-Deficiency
Colorectal Cancer
Keywords: Patient blood management
Lead sponsor: Prince of Wales Hospital, Shatin, Hong Kong
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Preoperative change in hemoglobin concentration (g/dL)
timeFrame: 3 weeks to 10 weeks
measure: Preoperative change in serum ferritin (mcg/L)
timeFrame: 3 weeks to 10 weeks
Secondary outcomes:
measure: Units of red blood cells transfused in perioperative period
timeFrame: 3 weeks to 12 weeks
measure: Duration of hospital stay (days)
timeFrame: 1 days up to 1 month
measure: Quality of recovery as measured by questionnaire (QoR-15(Chinese))
timeFrame: post op day 3
measure: Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions
timeFrame: up to post op day 30
measure: Rate of surgical complications
timeFrame: up to post op day 30
measure: Days (alive and) at home within 30 days of surgery (DAH30)
timeFrame: up to post op day 30
Other outcomes:
measure: Patient recruitment rate(%)
timeFrame: through study completion, an average of 1 year
measure: Number of patients recruited per month
timeFrame: through study completion, an average of 1 year
measure: Median waiting time to surgery (days)
timeFrame: through study completion, an average of 1 year
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References:
citation: Fung PLP, Lau VNM, Ng FF, Leung WW, Mak TWC, Lee A. Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial. PLoS One. 2022 Jun 30;17(6):e0270640. doi: 10.1371/journal.pone.0270640. eCollection 2022.