Anemia, Iron-DeficiencyPhase 3NCT03565354
Efficacy of Preoperative Intravenous Iron in Anaemic Colorectal Cancer Surgical Patients
A Phase 3 study testing iron isomaltoside(Monofer®) in people with Anemia, Iron-Deficiency and Colorectal Cancer, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Iron-Deficiency, Colorectal Cancer
- What is being tested?
- iron isomaltoside(Monofer®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2018to 30 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- iron isomaltoside(Monofer®)
- Keywords
- Patient blood management
- Medical subject headings
- Anemia, Iron-Deficiency, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron isomaltoside(Monofer®)Drug
intravenous iron isomaltoside
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative change in hemoglobin concentration (g/dL)
the difference between the value at diagnosis(baseline) and preoperative day (3-10weeks after diagnosis).
Measured: 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).
Measured: 3 weeks to 10 weeks
Secondary outcomes (6)
Units of red blood cells transfused in perioperative period
Units of red blood cells transfused from diagnosis to discharge
Measured: 3 weeks to 12 weeks
Duration of hospital stay (days)
Measured: 1 days up to 1 month
Quality of recovery as measured by questionnaire (QoR-15(Chinese))
Measured: post op day 3
Incidence of adverse reactions/serious adverse events to intravenous iron administration and adverse reaction to blood transfusions
Measured: up to post op day 30
Rate of surgical complications
recorded and graded according to Clavien Classification of Surgical Complications
Measured: up to post op day 30
Days (alive and) at home within 30 days of surgery (DAH30)
Measured: up to post op day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Jul 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron-DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Pui Lam Polly FUNG, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565354
- Sponsor's protocol ID
- NTEC-2018-0169
- Status last verified
- Jul 2020
- First submitted
- 28 May 2018
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35771891
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03565354
- Acronym / sponsor ID
- NTEC-2018-0169
- Conditions
- Anemia, Iron-Deficiency, Colorectal Cancer
- Keywords
- Patient blood management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Drug: iron isomaltoside(Monofer®)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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iron isomaltoside(Monofer®)intravenous iron isomaltoside | Drug | Treatment arm |
Primary outcome
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).
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).
6 secondary outcomes
Units of red blood cells transfused in perioperative period
Time frame: 3 weeks to 12 weeks
Duration of hospital stay (days)
Time frame: 1 days up to 1 month
Quality of recovery as measured by questionnaire (QoR-15(Chinese))
Time frame: post op day 3
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
Rate of surgical complications
Time frame: up to post op day 30
Days (alive and) at home within 30 days of surgery (DAH30)
Time frame: up to post op day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Derived from this study: PubMed 35771891Fung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing iron isomaltoside(Monofer®) in people with Anemia, Iron-Deficiency and Colorectal Cancer, run by Prince of Wales Hospital, Shatin, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative change in hemoglobin concentration (g/dL) (time frame: 3 weeks to 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.