Coronary Artery DiseasePhase 4PREFER-CABGNCT03574311
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery
A Phase 4 study testing Ferric carboxymaltose and Physiological saline in people with Coronary Artery Disease and Postoperative Complications, run by Turku University Hospital at 1 site in Finland.
Trial summary
This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Postoperative Complications, Aortic Valve Stenosis
- What is being tested?
- Ferric carboxymaltose and Physiological saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteFinland
- Study dates
- 2 Oct 2018to Dec 2023
- 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
- Patients presenting with cardiac disease requiring surgical operation
- Open heart surgery is considered the best appropriate treatment strategy according to the current guidelines.
- significant three vessel disease
- left main disease ± single, two or three vessel disease
- two-vessel disease with proximal LAD stenosis
- coronary artery disease requiring revascularization not amenable to percutaneous coronary intervention
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- Aortic valve disease requiring aortic valve surgery
- Mitral valve disease requiring surgical mitral surgery
- Combined surgery for revascularization and valve disease
- surgery of ascending aorta
- Have provided signed written informed consent
Who cannot join
- Age < 35 years
- Patients requiring , emergency or salvage cardiac surgical operation
- Participation in another clinical study or treatment with another investigational product 30 days prior to randomization
- Moribund patient not expected to survive surgery 12 months after surgery
- Active malignant disease with a short life expectancy, not eligible for surgery
- Hemoglobin levels > 155 g/dL for women and >167 g/dl for men (upper reference limits for TYKSlab)
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- Ferritin levels >150 ug/l for women and >400 ug/l for men.
- Renal dialysis therapy for chronic renal failure or severe preoperative renal impairment (eGFR<30ml/min).
- Study treatment can't be infused during the required time window: minimum 48 hours and maximum 21 days before the operation.
- Ongoing oral or parenteral iron medication at the time of randomization
- Iron or haemoglobin metabolism or synthesis disorders
- Primary or secondary hemochromatosis (in males and postmenopausal females, a serum ferritin value of over 300 ng/mL (670 pmol/L); and in premenopausal females, a serum ferritin value of over 150[17] or 200[18] ng/mL (330 or 440 pmol/L) indicates iron overload).
- Porphyria cutanea tarda.
- Liver failure (Child-Pugh class B or C).
- Pregnancy.
- Body weight less than 50kg.
- Ongoing antibiotic treatment other than prophylactic urine tract infection antibiotics.
Trial locations and contacts
1 site in 1 country.
Tuija Vasankari, RN contact
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, 20521
Jarmo M Gunn, PhD, +35823130548, jarmo.gunn@tyks.fi
Tuija Vasankari, RN, +35823130000, tuija.vasankari@tyks.fi
About this study
Official title: A Phase IV Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective or Urgent Cardiac Surgery
This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Half of the patients will receive ferric carboxymaltose and half of the patients physiological saline solution as placebo.
- Conditions
- Coronary Artery Disease, Postoperative Complications, Aortic Valve Stenosis, Mitral Valve Disease, Aortic Aneurysm, Thoracic
- Being tested
- Ferric carboxymaltose, Physiological saline
- Keywords
- CABG, cardiac surgery, blood transfusion, intravenous iron, postoperative infection
- Medical subject headings
- Coronary Artery Disease, Postoperative Complications, Aortic Valve Stenosis, Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric carboxymaltoseDrug
A single dose of drug or placebo is administered preoperatively to participants
Physiological salineOther
Single infusion 100 ml physiological saline infusion preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Ferric carboxymaltose | Experimental | Preoperative 1000 mg intravenous single dose as 30 minute infusion Receives: Drug: Ferric carboxymaltose |
| Placebo | Placebo comparator | Preoperative 100 ml saline as 30 minute infusion Receives: Other: Physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of allogeneic blood transfusion and/or nosocomial infection
Composite of transfused red blood cell units and/or nosocomial infection
Measured: 0-90 days
Secondary outcomes (11)
Mortality
All-cause mortality
Measured: 0-90 days
ICU/CCU days
Days in the ICU (intensive care unit) and/or CCU (cardiac care unit)
Measured: 0-90 days
Perioperative myocardial infarction
MI (myocardial infarction) assessed by postoperative CK-Mbm or Troponin t levels
Measured: 3 days
Length of stay
Days in hospital
Measured: 0-90 days
Days on vasoactive drugs
Days on vasopressors (e.g. epinephrine, norepinephrine, milrinone etc.)
Measured: 0-90 days
Ventilator free days
Days not on ventilator (intubated or non-invasive ventilation)
Measured: 0-90 days
AKI (acute kidney injury)
Rate of acute renal failure
Measured: 0-90 days
New onset atrial fibrillation (AF) or flutter
New AF or flutter (i.e. patient without previous history of AF/flutter) assessed from ECG-telemetry during index hospitalization or ECG-verified AF/flutter after discharge
Measured: 0-90 days
Acute heart failure
Acute congestive heart failure (diagnosed by a clinician) requiring hospitalization
Measured: 90 days
Worsening heart failure
Worsening to NYHA -class (New York Heart Association) III/IV or readmission for heart failure
Measured: 0-90 days
Health related quality of life
Assessed with self-reporting questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start2 Oct 2018
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled 1:1
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574311
- Sponsor's protocol ID
- PREFER-CPB01
- Acronym
- PREFER-CABG
- Status last verified
- Apr 2021
- First submitted
- 14 Jun 2018
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective or Urgent Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03574311
- Acronym / sponsor ID
- PREFER-CABG / PREFER-CPB01
- Conditions
- Coronary Artery Disease, Postoperative Complications, Aortic Valve Stenosis, Mitral Valve Disease, Aortic Aneurysm, Thoracic
- Keywords
- CABG, cardiac surgery, blood transfusion, intravenous iron, postoperative infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Vifor Pharma
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 29 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.
This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Half of the patients will receive ferric carboxymaltose and half of the patients physiological saline solution as placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled 1:1
| Arm | Type | Receives |
|---|---|---|
| Ferric carboxymaltose | Experimental | Drug: Ferric carboxymaltosePreoperative 1000 mg intravenous single dose as 30 minute infusion |
| Placebo | Placebo comparator | Other: Physiological salinePreoperative 100 ml saline as 30 minute infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients presenting with cardiac disease requiring surgical operation
- Open heart surgery is considered the best appropriate treatment strategy according to the current guidelines.
- Have provided signed written informed consent
Key exclusion criteria (17 listed)
- Age < 35 years
- Patients requiring , emergency or salvage cardiac surgical operation
- Participation in another clinical study or treatment with another investigational product 30 days prior to randomization
- Moribund patient not expected to survive surgery 12 months after surgery
- Active malignant disease with a short life expectancy, not eligible for surgery
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 |
|---|---|---|
| Ferric carboxymaltoseA single dose of drug or placebo is administered preoperatively to participants | Drug | Ferric carboxymaltose |
| Physiological salineSingle infusion 100 ml physiological saline infusion preoperatively | Other | Placebo |
Primary outcome
Incidence of allogeneic blood transfusion and/or nosocomial infection
Time frame: 0-90 days
Composite of transfused red blood cell units and/or nosocomial infection
11 secondary outcomes
Mortality
Time frame: 0-90 days
ICU/CCU days
Time frame: 0-90 days
Perioperative myocardial infarction
Time frame: 3 days
Length of stay
Time frame: 0-90 days
Days on vasoactive drugs
Time frame: 0-90 days
Ventilator free days
Time frame: 0-90 days
AKI (acute kidney injury)
Time frame: 0-90 days
New onset atrial fibrillation (AF) or flutter
Time frame: 0-90 days
Acute heart failure
Time frame: 90 days
Worsening heart failure
Time frame: 0-90 days
Health related quality of life
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- 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.
Tuija Vasankari, RN contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric carboxymaltose and Physiological saline in people with Coronary Artery Disease and Postoperative Complications, run by Turku University Hospital at 1 site in Finland.
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 11 inclusion and 17 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 20 Apr 2021. 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 Finland. 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. Some participants in this study may receive a placebo. 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 Jarmo M Gunn, adj. professor (+35823130000, jarmo.gunn@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of allogeneic blood transfusion and/or nosocomial infection (time frame: 0-90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2021.