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NCT Number: NCT03565354

Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients

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.

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Key information

Conditions

Anemia, Iron-Deficiency Anemia Anemia, Hypochromic Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Intestinal Diseases Intestinal Neoplasms Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iron isomaltoside(Monofer®)

Drug

intravenous iron isomaltoside

Primary outcomes

  1. Preoperative change in hemoglobin concentration (g/dL)

    Time frame: 3 weeks to 10 weeks

    the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).

  2. Preoperative change in serum ferritin (mcg/L)

    Time frame: 3 weeks to 10 weeks

    the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).

Secondary outcomes

  1. Units of red blood cells transfused in perioperative period

    Time frame: 3 weeks to 12 weeks

    Units of red blood cells transfused from diagnosis to discharge

  2. Duration of hospital stay (days)

    Time frame: 1 days up to 1 month

  3. Quality of recovery as measured by questionnaire (QoR-15(Chinese))

    Time frame: post op day 3

  4. 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

  5. Rate of surgical complications

    Time frame: up to post op day 30

    recorded and graded according to Clavien Classification of Surgical Complications

  6. Days (alive and) at home within 30 days of surgery (DAH30)

    Time frame: up to post op day 30

Other outcomes

  1. Patient recruitment rate(%)

    Time frame: through study completion, an average of 1 year

    number of recruited patients divided by number of eligible patients x 100%

  2. Number of patients recruited per month

    Time frame: through study completion, an average of 1 year

  3. Median waiting time to surgery (days)

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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