Complex Valvular Heart SurgeryNCT02862665
Effect of Perioperative Iron Isomaltoside 1000 Administration on Transfusion Requirements in Patients Undergoing Complex Valvular Heart Surgery: a Randomized Clinical Trial
A study testing iron isomaltoside 1000 (Monofer®) and normal saline 100 ml in people with Complex Valvular Heart Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
In complex cardiac surgery with prolonged cardiopulmonary bypass, allogeneic blood products transfusions are often necessary to control intraoperative and postoperative bleeding. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Complex Valvular Heart Surgery
- What is being tested?
- iron isomaltoside 1000 (Monofer®) and normal saline 100 ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to 7 May 2020
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the patients undergoing redo cardiac surgery or complex valvular heart surgery with cardiopulmonary bypass
- tha age ≥19 yrs old.
- the patients who are willing to provide written informed consent
Who cannot join
- having preoperative anemia (Hb <9 g/dl for women, Hb <10 g/dl for men)
- preoperative erythropoietin treatment within four weeks before surgery
- redo cardiac operation due to preoperative paravalvular leakage
- known hypersensitivity to any excipients in the investigational drug products
- aplastic anemia
- the patients who stay more than 48 hours in the intensive care unit preoperatively due to heart failure or other major complication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Thoracic and Cardiovascular Surgery, Cardiovascular Research Institute, Yonsei University College of Medicine
Seoul, 03722
About this study
In complex cardiac surgery with prolonged cardiopulmonary bypass, allogeneic blood products transfusions are often necessary to control intraoperative and postoperative bleeding. Furthermore, approximately 50% of all patients undergoing cardiac surgery are anemic before surgery, and patients with normal hemoglobin level may become anemic during and/or after surgery. Perioperative transfusion carries risks far beyond transmission of infection and has been demonstrated to be associated with adverse outcomes related to postoperative pulmonary complications, decreased renal function and increased mortality. Thus, the important of blood conservation stratigies to minimize transfusion is being increasingly emphasized. In recent trial by Johansson and colleagues, they concluded that the perioperative administration of intravenous iron isomaltoside 1000 increased the hemoglobin level and prevented anemia 4 weeks after cardiac surgery. Therefore, perioperative iron isomaltoside 1000 administration among the patients undergoing complex valvular heart surgery could reduce not only the perioperative allogeneic transfusion but also the incidence of postoperative adverse events. The aim of this study is to examine the effect of perioperative iron isomaltoside 1000 administration on transfusion requirements in patients undergoing complex valvular heart surgery.
- Conditions
- Complex Valvular Heart Surgery
- Being tested
- iron isomaltoside 1000 (Monofer®), normal saline 100 ml
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iron isomaltoside 1000 (Monofer®)Drug
The patients will receive iron isomaltoside 1000 (Monofer®) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery. They will receive iron isomaltoside 1000 (Monofer®) 1000 mg over 15 min.
normal saline 100 mlDrug
The patients will receive normal saline 100 ml as an i.v. infusion twice; 3 days before surgery and 3 days after surgery. They will receive normal saline 100 ml over 15 min.
| Study group | Role | What they receive |
|---|---|---|
| IV iron | Experimental | The patients will receive iron isomaltoside 1000 (Monofer®) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery. They will receive iron isomaltoside 1000 (Monofer®) 1000 mg over 15 min. Receives: Drug: iron isomaltoside 1000 (Monofer®) |
| Control | Placebo comparator | The patients will receive normal saline 100 ml as an i.v. infusion twice; 3 days before surgery and 3 days after surgery. They will receive normal saline 100 ml over 15 min. Receives: Drug: normal saline 100 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients who need blood transfusion
Investigator will assess the number of patients in each group who will need blood transfusion during hospital stays, and evaluate the effect of iron isomaltoside 1000 (Monofer®) on perioperative blood transfusion.
Measured: patients will be followed for the duration of hospital stay, an expected average of 10 days after surgery
Secondary outcomes (3)
the proportion of patients who will experience postoperative adverse events
Investigator will assess the number of patients in each group who will experience postoperative adverse events (death, atrial fibrillation, reoperation, wound infection, acute kidney injury, permanent stroke, prolonged mechanical ventilation or postoperative myocardial infarction) within the first 20 days after surgery, and evaluate the effect of iron isomaltoside 1000 (Monofer®) on the occurrence of any postoperative adverse events.
Measured: within the first 20 days after surgery. (plus or minus 3 days)
the plasma hepcidin concentrations of patients
Investigator will assess the plasma hepcidin concentrations before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery, and evaluate the association between the plasma hepcidin concentrations and the effect of iron isomaltoside 1000 (Monofer®) or the occurrence of any postoperative adverse events.
Measured: before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery
the plasma EPO (erythropoietin) concentrations of patients
Investigator will assess the plasma EPO concentrations before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery, and evaluate the association between the plasma EPO concentrations and the effect of iron isomaltoside 1000 (Monofer®) or the occurrence of any postoperative adverse events.
Measured: before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion7 May 2020
- Study completion7 May 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 Complex Valvular Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862665
- Sponsor's protocol ID
- 4-2016-0502
- Status last verified
- Aug 2020
- First submitted
- 8 Aug 2016
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee SH, Shim JK, Soh S, Song JW, Chang BC, Lee S, Kwak YL. The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer(R)) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial. Trials. 2018 Jul 4;19(1):350. doi: 10.1186/s13063-018-2545-3.
PubMed 29973224
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Iron Isomaltoside 1000 Administration on Transfusion Requirements in Patients Undergoing Complex Valvular Heart Surgery: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02862665
- Acronym / sponsor ID
- 4-2016-0502
- Conditions
- Complex Valvular Heart Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 11 Aug 2016 (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.
In complex cardiac surgery with prolonged cardiopulmonary bypass, allogeneic blood products transfusions are often necessary to control intraoperative and postoperative bleeding. Furthermore, approximately 50% of all patients undergoing cardiac surgery are anemic before surgery, and patients with normal hemoglobin level may become anemic during and/or after surgery. Perioperative transfusion carries risks far beyond transmission of infection and has been demonstrated to be associated with adverse outcomes related to postoperative pulmonary complications, decreased renal function and increased mortality. Thus, the important of blood conservation stratigies to minimize transfusion is being increasingly emphasized. In recent trial by Johansson and colleagues, they concluded that the perioperative administration of intravenous iron isomaltoside 1000 increased the hemoglobin level and prevented anemia 4 weeks after cardiac surgery. Therefore, perioperative iron isomaltoside 1000 administration among the patients undergoing complex valvular heart surgery could reduce not only the perioperative allogeneic transfusion but also the incidence of postoperative adverse events. The aim of this study is to examine the effect of perioperative iron isomaltoside 1000 administration on transfusion requirements in patients undergoing complex valvular heart surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV iron | Experimental | Drug: iron isomaltoside 1000 (Monofer®)The patients will receive iron isomaltoside 1000 (Monofer®) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery. They will receive iron isomaltoside 1000 (Monofer®) 1000 mg over 15 min. |
| Control | Placebo comparator | Drug: normal saline 100 mlThe patients will receive normal saline 100 ml as an i.v. infusion twice; 3 days before surgery and 3 days after surgery. They will receive normal saline 100 ml over 15 min. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the patients undergoing redo cardiac surgery or complex valvular heart surgery with cardiopulmonary bypass
- tha age ≥19 yrs old.
- the patients who are willing to provide written informed consent
Key exclusion criteria (6 listed)
- having preoperative anemia (Hb <9 g/dl for women, Hb <10 g/dl for men)
- preoperative erythropoietin treatment within four weeks before surgery
- redo cardiac operation due to preoperative paravalvular leakage
- known hypersensitivity to any excipients in the investigational drug products
- aplastic anemia
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 1000 (Monofer®)The patients will receive iron isomaltoside 1000 (Monofer®) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery. They will receive iron isomaltoside 1000 (Monofer®) 1000 mg over 15 min. | Drug | IV iron |
| normal saline 100 mlThe patients will receive normal saline 100 ml as an i.v. infusion twice; 3 days before surgery and 3 days after surgery. They will receive normal saline 100 ml over 15 min. | Drug | Control |
Primary outcome
the proportion of patients who need blood transfusion
Time frame: patients will be followed for the duration of hospital stay, an expected average of 10 days after surgery
Investigator will assess the number of patients in each group who will need blood transfusion during hospital stays, and evaluate the effect of iron isomaltoside 1000 (Monofer®) on perioperative blood transfusion.
3 secondary outcomes
the proportion of patients who will experience postoperative adverse events
Time frame: within the first 20 days after surgery. (plus or minus 3 days)
the plasma hepcidin concentrations of patients
Time frame: before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery
the plasma EPO (erythropoietin) concentrations of patients
Time frame: before the investigational drug i.v. infusion; 3 days before surgery and 3 days after surgery
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 18 Aug 2020.
- Derived from this study: PubMed 29973224Lee SH, Shim JK, Soh S, Song JW, Chang BC, Lee S, Kwak YL. The effect of perioperative intravenously administered iron isomaltoside 1000 (Monofer(R)) on transfusion requirements for patients undergoing complex valvular heart surgery: study protocol for a randomized controlled trial. Trials. 2018 Jul 4;19(1):350. doi: 10.1186/s13063-018-2545-3.
- Individual participant dataSharing planned: No
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 study testing iron isomaltoside 1000 (Monofer®) and normal saline 100 ml in people with Complex Valvular Heart Surgery, run by Yonsei University at 1 site in South Korea.
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 6 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 18 Aug 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 South Korea. 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.
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?
the proportion of patients who need blood transfusion (time frame: patients will be followed for the duration of hospital stay, an expected average of 10 days after 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 NCT02862665, 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 18 Aug 2020; AzTrials last refreshed its copy on 7 Nov 2026.