AnemiaPhase 4FITNCT02243735
Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion as Treatment of Anaemia
A Phase 4 study testing Ferrous fumarate and ferric(III)carboxymaltose in people with Anemia and Colorectal Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 13 sites in Netherlands.
Trial summary
The aim of this multicenter trial is to determine the efficacy of preoperative intravenous iron suppletion in comparison with the standard preoperative oral substitution in anaemic patients with colorectal cancer in curing the anemia and the assess the effect of preoperative iron on morbidity, postoperative recovery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia, Colorectal Carcinoma, Surgery
- What is being tested?
- Ferrous fumarate and ferric(III)carboxymaltose
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 13 sitesNetherlands
- Study dates
- Nov 2014to Dec 2019
- Phase
- Phase 4
- 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
- M0-stage Colorectal carcinoma
- Laparoscopic or open segmental colonic resection or (low) anterior resection
- Iron deficiency anaemia: Hb <7,5 mmol/l (12 g/dl) for women and Hb < 8 mmol/l (13 g/dl) for men and TSAT<20%
- Age 18 or older
- Written informed consent for study participation
Who cannot join
- Palliative surgery / metastasized disease
- Received blood transfusion within one month before screening
- Serum ferritin ≥ 800 µg/L
- Pregnancy
- Preoperative chemoradiation (Short course radiotherapy (5x5 Gy) = no exclusion)
- Contraindication for the use of ferric(III)carboxymaltose or ferrofumarate
Show all 15Show fewer
- ASA classification > 3
- Use of erythropoietin stimulating agents within three months before screening
- Chronic kidney disease (GFR < 30ml/min/m)
- Myelodysplastic syndrome
- Severe anaemia with indication for blood transfusion
- Elevated liver enzymes (more than three times normal value)
- Hereditary Hemochromatosis
- Thalassemia
- Haemolytic anaemia/ chronic haemolysis
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites, 13 recruiting
- Not yet recruiting
Medisch Centrum Alkmaar
Alkmaar
L Houdijk, MD, a.p.j.houdijk@mca.nl
- Not yet recruiting
Flevoziekenhuis
Almere Stad
A Van de ven, a.w.vandeven@amc.uva.nl
- Not yet recruiting
Meander Ziekenhuis
Amersfoort
E Consten, ECJ.Consten@meandermc.nl
- Recruiting
Academic Medical Center
Amsterdam, 1100DD
Wernard Borstlap, w.a.borstlap@amc.uva.nl
willem bemelman, md
- Recruiting
Onze Lieve Vrouwe Gasthuis
Amsterdam
M Gerhards, MD, m.f.gerhards@olvg.nl
- Recruiting
Sint Lucas Andreas Ziekenhuis
Amsterdam
Bart van Wagensveld, Md, Phd
- Not yet recruiting
Spaarne ziekenhuis
Amsterdam
Q Eijsbouts, MD, qeijsbouts@spaarneziekenhuis.nl
- Not yet recruiting
VU medical center
Amsterdam
Jurriaan Tuynman, MD, j.tuynman@vumc.nl
- Recruiting
Study site
Amsterdam
- Not yet recruiting
Gelre Ziekenhuis
Apeldoorn
E. van der Zaag, MD, e.van.der.zaag@gelre.nl
- Not yet recruiting
Albert Schweizer Ziekenhuis
Dordrecht
J van der Hoeven, MD, .a.b.vander.hoeven@asz.nl
- Not yet recruiting
Tergooi ziekenhuis
Hilversum
N van geloven, MD, avangeloven@tergooi.nl)
- Not yet recruiting
Haga Ziekenhuis
The Hague
W Steup, MD, w.steup@hagaziekenhuis.nl
About this study
Official title: Multicenter Randomized Controlled Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion in the Treatment of Preoperative Anaemia in Colorectal Cancer Patients
The aim of this multicenter trial is to determine the efficacy of preoperative intravenous iron suppletion in comparison with the standard preoperative oral substitution in anaemic patients with colorectal cancer in curing the anemia and the assess the effect of preoperative iron on morbidity, postoperative recovery and quality of life.
Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with intravenous iron will lead to a higher percentage of patients with normalization of Hb-level (> 12 g/dl (7.5 mmol/l) for women and > 13 g/dl (8 mmol/l) for men), which potentially reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be more cost effective compared to current practice with oral substitution of iron.
Read the detailed description
This multicenter randomized clinical trial aims to optimize postoperative outcome in anaemic patients who undergo curative surgery for colorectal carcinoma. The aim of this trial is to investigate which route of administration is superior in the treatment of iron deficiency anaemia in these patients. In addition, an economic evaluation of intravenous iron versus oral iron will be done. The evaluation will be performed from a societal perspective as (i) a cost-effectiveness analysis with the costs per responder to iron suppletion therapy as primary outcome and (ii) a cost-utility analysis with the costs per quality adjusted life-year (QALY) as primary outcome. The cost effectiveness analysis closely relates to clinical efficacy measure and allows for setting priorities in treatment of anaemia in colorectal cancer patients. The cost-utility analysis allows for a comparison of the societal impact of intravenous iron suppletion on post-operative recovery, such as shorter length of stay and earlier return to daily activities, with the impact of other interventions and of interventions in other areas of health care.
The primary aim of this trial is:
- To compare the percentage of patients with normalization of Hb-level (> 12 g/dl (7.5 mmol/l) for women and > 13 g/dl (8 mmol/l) for men after intravenous versus oral iron therapy in patients undergoing curative surgery for colorectal carcinoma. Secondary aims of the FIT trial are:
- To analyse the effect of preoperative iron therapy (intravenous versus oral) on postoperative morbidity, length of stay, amount of blood transfusions needed and quality of life and fatigue scores.
- To determine the cost effectiveness of preoperative intravenous iron substitution in comparison with oral substitution.
Sample size:
The principal analysis will consist of an intention-to-treat comparison of the proportions of patients with iron deficiency anaemia between the two study groups. The trial is designed as a superiority trial, hypothesizing a greater percentage of patients achieving normalization of Hb-level (called 'responder') in favour of infusion of ferric(III)carboxymaltose compared to oral iron suppletion. Our power calculation is based on the study of Seid et al(19), which compared ferric(III)carboxymaltose with oral ferrous sulphate in a population of post-partum women with an iron deficiency anaemia. The proportion achieving a normalization of Hb after two weeks of treatment was 55% in the intravenous iron group and 35% in the oral iron group. We expect that the efficacy of the iron therapy is lower in patients with a colorectal carcinoma. Therefore, the expected percentage of patients who achieve normalization of Hb-level (Hb >7.5 mmol/l (12 g/dl) for women and Hb >8.o mmol/l (13 g/dl) for men) is 45% in the intravenous iron group and 25% in the oral iron group. Based on these proportions, a sample size of 89 patients per group is needed for a Chi square test to achieve 80% power at a two sided alpha of 0.05. With an estimated loss to follow up of 10%, a sample size of 198 is calculated. We used nQuery advisor version 7.0 to calculate the sample size.
- Conditions
- Anemia, Colorectal Carcinoma, Surgery
- Being tested
- Ferrous fumarate, ferric(III)carboxymaltose
- Medical subject headings
- Anemia, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous fumarateDrug
Also called ferrofumarate
Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery
ferric(III)carboxymaltoseDrug
Also called Ferinject
Patients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered
| Study group | Role | What they receive |
|---|---|---|
| Ferrous fumarate | Active comparator | Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery Receives: Drug: Ferrous fumarate |
| ferric(III)carboxymaltose | Active comparator | Patients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered Receives: Drug: ferric(III)carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of Hb-level.
Percentage of patients with normalization of Hb-level from start treatment until day of admission for surgery. (Hb >12g/dl (7.5mmol/L) for women and Hb >13 g/dl (8.0mmol/L) for men).
Patient will be randomised after they visit the surgery outpatient clinic to discuss the treatment option for their colorectal carcinoma. Average time between this visit and surgery in the Netherlands is maximally 5 weeks. Patients on oral iron suppletion will start with the iron therapy on the day of the randomisation. For the patients that will receive intravenous iron an appointment will be made on the short-care unit to facilitate the infusion of the iron. The period between infusion and surgery should be longer than two weeks.
Our primary endpoint: Percentage of patients with normalization of Hb-level. Will be measured at the day of admission before surgery. Which is one day prior to surgery. The Hb-level will be followed-up after surgery on postoperative day 1, day 7 and after 4,8 and 12 weeks.
Measured: From Baseline (date of randomisation) untill day of admission for surgery
Secondary outcomes (1)
Difference in Morbidity score
The difference in morbidity score will be assessed using the Comprehensive Complication index, between both study groups
Measured: postoperative at week 1, week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Principal investigator, Prof. dr. W.A. Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- W. A Bemelman, Proffessor, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243735
- Sponsor's protocol ID
- NL50013.018.14
- Other IDs
- 2014-002827-87, 2014
- Acronym
- FIT
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Talboom K, Borstlap WAA, Roodbeen SX, Bruns ERJ, Buskens CJ, Hompes R, Tytgat KMAJ, Tuynman JB, Consten ECJ, Heuff G, Kuiper T, van Geloven AAW, Veldhuis GJ, van der Hoeven JAB, Gerhards MF, Sietses C, Spinelli A, van de Ven AWH, van der Zaag ES, Westerterp M, van Westreenen HL, Dijkgraaf ML, Juffermans NP, Bemelman WA; FIT collaborative group. Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial. Lancet Haematol. 2023 Apr;10(4):e250-e260. doi: 10.1016/S2352-3026(22)00402-1. Epub 2023 Feb 27.
PubMed 36863386Borstlap WAA, Buskens CJ, Tytgat KMAJ, Tuynman JB, Consten ECJ, Tolboom RC, Heuff G, van Geloven N, van Wagensveld BA, C A Wientjes CA, Gerhards MF, de Castro SMM, Jansen J, van der Ven AWH, van der Zaag E, Omloo JM, van Westreenen HL, Winter DC, Kennelly RP, Dijkgraaf MGW, Tanis PJ, Bemelman WA. Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients. BMC Surg. 2015 Jun 28;15:78. doi: 10.1186/s12893-015-0065-6.
PubMed 26123286
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion in the Treatment of Preoperative Anaemia in Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT02243735
- Acronym / sponsor ID
- FIT / NL50013.018.14
- Conditions
- Anemia, Colorectal Carcinoma, Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- Nov 2014
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 18 Sep 2014 (estimated)
- 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.
The aim of this multicenter trial is to determine the efficacy of preoperative intravenous iron suppletion in comparison with the standard preoperative oral substitution in anaemic patients with colorectal cancer in curing the anemia and the assess the effect of preoperative iron on morbidity, postoperative recovery and quality of life.
Hypothesis: It is our hypothesis that a more profound approach of preoperative anaemia with intravenous iron will lead to a higher percentage of patients with normalization of Hb-level (> 12 g/dl (7.5 mmol/l) for women and > 13 g/dl (8 mmol/l) for men), which potentially reduces morbidity, length of stay, improves quality of live, decreases fatigue and could be more cost effective compared to current practice with oral substitution of iron.
Detailed description
This multicenter randomized clinical trial aims to optimize postoperative outcome in anaemic patients who undergo curative surgery for colorectal carcinoma. The aim of this trial is to investigate which route of administration is superior in the treatment of iron deficiency anaemia in these patients. In addition, an economic evaluation of intravenous iron versus oral iron will be done. The evaluation will be performed from a societal perspective as (i) a cost-effectiveness analysis with the costs per responder to iron suppletion therapy as primary outcome and (ii) a cost-utility analysis with the costs per quality adjusted life-year (QALY) as primary outcome. The cost effectiveness analysis closely relates to clinical efficacy measure and allows for setting priorities in treatment of anaemia in colorectal cancer patients. The cost-utility analysis allows for a comparison of the societal impact of intravenous iron suppletion on post-operative recovery, such as shorter length of stay and earlier return to daily activities, with the impact of other interventions and of interventions in other areas of health care.
The primary aim of this trial is:
- To compare the percentage of patients with normalization of Hb-level (> 12 g/dl (7.5 mmol/l) for women and > 13 g/dl (8 mmol/l) for men after intravenous versus oral iron therapy in patients undergoing curative surgery for colorectal carcinoma. Secondary aims of the FIT trial are:
- To analyse the effect of preoperative iron therapy (intravenous versus oral) on postoperative morbidity, length of stay, amount of blood transfusions needed and quality of life and fatigue scores.
- To determine the cost effectiveness of preoperative intravenous iron substitution in comparison with oral substitution.
Sample size:
The principal analysis will consist of an intention-to-treat comparison of the proportions of patients with iron deficiency anaemia between the two study groups. The trial is designed as a superiority trial, hypothesizing a greater percentage of patients achieving normalization of Hb-level (called 'responder') in favour of infusion of ferric(III)carboxymaltose compared to oral iron suppletion. Our power calculation is based on the study of Seid et al(19), which compared ferric(III)carboxymaltose with oral ferrous sulphate in a population of post-partum women with an iron deficiency anaemia. The proportion achieving a normalization of Hb after two weeks of treatment was 55% in the intravenous iron group and 35% in the oral iron group. We expect that the efficacy of the iron therapy is lower in patients with a colorectal carcinoma. Therefore, the expected percentage of patients who achieve normalization of Hb-level (Hb >7.5 mmol/l (12 g/dl) for women and Hb >8.o mmol/l (13 g/dl) for men) is 45% in the intravenous iron group and 25% in the oral iron group. Based on these proportions, a sample size of 89 patients per group is needed for a Chi square test to achieve 80% power at a two sided alpha of 0.05. With an estimated loss to follow up of 10%, a sample size of 198 is calculated. We used nQuery advisor version 7.0 to calculate the sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous fumarate | Active comparator | Drug: Ferrous fumaratePatients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery |
| ferric(III)carboxymaltose | Active comparator | Drug: ferric(III)carboxymaltosePatients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- M0-stage Colorectal carcinoma
- Laparoscopic or open segmental colonic resection or (low) anterior resection
- Iron deficiency anaemia: Hb <7,5 mmol/l (12 g/dl) for women and Hb < 8 mmol/l (13 g/dl) for men and TSAT<20%
- Age 18 or older
- Written informed consent for study participation
Key exclusion criteria (15 listed)
- Palliative surgery / metastasized disease
- Received blood transfusion within one month before screening
- Serum ferritin ≥ 800 µg/L
- Pregnancy
- Preoperative chemoradiation (Short course radiotherapy (5x5 Gy) = no exclusion)
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 |
|---|---|---|
| Ferrous fumarateAlso: ferrofumaratePatients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery | Drug | Ferrous fumarate |
| ferric(III)carboxymaltoseAlso: FerinjectPatients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered | Drug | ferric(III)carboxymaltose |
Primary outcome
Normalization of Hb-level.
Time frame: From Baseline (date of randomisation) untill day of admission for surgery
Percentage of patients with normalization of Hb-level from start treatment until day of admission for surgery. (Hb >12g/dl (7.5mmol/L) for women and Hb >13 g/dl (8.0mmol/L) for men). Patient will be randomised after they visit the surgery outpatient clinic to discuss the treatment option for their colorectal carcinoma. Average time between this visit and surgery in the Netherlands is maximally 5 weeks. Patients on oral iron suppletion will start with the iron therapy on the day of the randomisation. For the patients that will receive intravenous iron an appointment will be made on the short-care unit to facilitate the infusion of the iron. The period between infusion and surgery should be longer than two weeks. Our primary endpoint: Percentage of patients with normalization of Hb-level. Will be measured at the day of admission before surgery. Which is one day prior to surgery. The Hb-level will be followed-up after surgery on postoperative day 1, day 7 and after 4,8 and 12 weeks.
1 secondary outcome
Difference in Morbidity score
Time frame: postoperative at week 1, week 4, week 8 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Derived from this study: PubMed 36863386Talboom K, Borstlap WAA, Roodbeen SX, Bruns ERJ, Buskens CJ, Hompes R, Tytgat KMAJ, Tuynman JB, Consten ECJ, Heuff G, Kuiper T, van Geloven AAW, Veldhuis GJ, van der Hoeven JAB, Gerhards MF, Sietses C, Spinelli A, van de Ven AWH, van der Zaag ES, Westerterp M, van Westreenen HL, Dijkgraaf ML, Juffermans NP, Bemelman WA; FIT collaborative group. Ferric carboxymaltose infusion versus oral iron supplementation for preoperative iron deficiency anaemia in patients with colorectal cancer (FIT): a multicentre, open-label, randomised, controlled trial. Lancet Haematol. 2023 Apr;10(4):e250-e260. doi: 10.1016/S2352-3026(22)00402-1. Epub 2023 Feb 27.
- Derived from this study: PubMed 26123286Borstlap WAA, Buskens CJ, Tytgat KMAJ, Tuynman JB, Consten ECJ, Tolboom RC, Heuff G, van Geloven N, van Wagensveld BA, C A Wientjes CA, Gerhards MF, de Castro SMM, Jansen J, van der Ven AWH, van der Zaag E, Omloo JM, van Westreenen HL, Winter DC, Kennelly RP, Dijkgraaf MGW, Tanis PJ, Bemelman WA. Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients. BMC Surg. 2015 Jun 28;15:78. doi: 10.1186/s12893-015-0065-6.
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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.
W. A Bemelman, Proffessor principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferrous fumarate and ferric(III)carboxymaltose in people with Anemia and Colorectal Carcinoma, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 13 sites in Netherlands.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wernard A Borstlap, MD (0031-(0)20- 5662670, w.a.borstlap@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization of Hb-level. (time frame: From Baseline (date of randomisation) untill day of admission for surgery). 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 NCT02243735, which also lists 2 linked publications.
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 28 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.