Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients

NCT03565354 | Completed Phase 3

• 1 other identifier: NTEC-2018-0169
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia, Iron-Deficiency; Colorectal Cancer

Keywords

Patient blood management

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Units of red blood cells transfused in perioperative period

  3 weeks to 12 weeks

• 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

• 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

Other Outcomes (3)

• Patient recruitment rate(%)

  through study completion, an average of 1 year

• Number of patients recruited per month

  through study completion, an average of 1 year

• Median waiting time to surgery (days)

  through study completion, an average of 1 year

Study Arms (2)

Treatment arm

ACTIVE COMPARATOR

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®)

Control arm

NO INTERVENTION

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.

Interventions

iron isomaltoside(Monofer®) DRUG

intravenous iron isomaltoside

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 35771891 DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident trainee

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 21, 2018
• Study Start: July 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)