Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565354
• Other study ID #: NTEC-2018-0169
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2020
• Source: Prince of Wales Hospital, Shatin, Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 de?ciency)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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• iron isomaltoside(Monofer®)
intravenous iron isomaltoside

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Wales Hospital, Shatin, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient recruitment rate(%)	number of recruited patients divided by number of eligible patients x 100%	through study completion, an average of 1 year
Other	Number of patients recruited per month		through study completion, an average of 1 year
Other	Median waiting time to surgery (days)		through study completion, an average of 1 year
Primary	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
Primary	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	Units of red blood cells transfused in perioperative period	Units of red blood cells transfused from diagnosis to discharge	3 weeks to 12 weeks
Secondary	Duration of hospital stay (days)		1 days up to 1 month
Secondary	Quality of recovery as measured by questionnaire (QoR-15(Chinese))		post op day 3
Secondary	Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions		up to post op day 30
Secondary	Rate of surgical complications	recorded and graded according to Clavien Classification of Surgical Complications	up to post op day 30
Secondary	Days (alive and) at home within 30 days of surgery (DAH30)		up to post op day 30