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Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients

Primary Purpose

Anemia, Iron-Deficiency, Colorectal Cancer

Status

Completed

Phase

Phase 3

Locations

Hong Kong

Study Type

Interventional

Intervention

iron isomaltoside(Monofer®)

About this trial

This is an interventional treatment trial for Anemia, Iron-Deficiency focused on measuring Patient blood management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treatment arm

Control arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Preoperative change in hemoglobin concentration (g/dL)

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

Preoperative change in serum ferritin (mcg/L)

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

Secondary Outcome Measures

Units of red blood cells transfused in perioperative period

Units of red blood cells transfused from diagnosis to discharge

Duration of hospital stay (days)

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

Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions

Rate of surgical complications

recorded and graded according to Clavien Classification of Surgical Complications

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

Full Information

NCT ID

NCT03565354

First Posted

May 28, 2018

Last Updated

July 17, 2020

Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT03565354

Brief Title

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

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Iron-Deficiency, Colorectal Cancer

Keywords

Patient blood management

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Active Comparator

Arm Description

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

iron isomaltoside(Monofer®)

Intervention Description

intravenous iron isomaltoside

Primary Outcome Measure Information:

Title

Preoperative change in hemoglobin concentration (g/dL)

Description

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

Time Frame

3 weeks to 10 weeks

Title

Preoperative change in serum ferritin (mcg/L)

Description

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

Time Frame

3 weeks to 10 weeks

Secondary Outcome Measure Information:

Title

Units of red blood cells transfused in perioperative period

Description

Units of red blood cells transfused from diagnosis to discharge

Time Frame

3 weeks to 12 weeks

Title

Duration of hospital stay (days)

Time Frame

1 days up to 1 month

Title

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

Time Frame

post op day 3

Title

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

Title

Rate of surgical complications

Description

recorded and graded according to Clavien Classification of Surgical Complications

Time Frame

up to post op day 30

Title

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

Time Frame

up to post op day 30

Other Pre-specified Outcome Measures:

Title

Patient recruitment rate(%)

Description

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

Time Frame

through study completion, an average of 1 year

Title

Number of patients recruited per month

Time Frame

through study completion, an average of 1 year

Title

Median waiting time to surgery (days)

Time Frame

through study completion, an average of 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Prince of Wales Hospital

City

Shatin

Country

Hong Kong

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35771891

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.

Results Reference

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Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients

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