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Coronary Artery DiseasePhase 4NCT04898569

Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response and Transfusion in Patients With Iron Deficiency Anemia After Off-Pump Coronary Artery Bypass Grafting

A Phase 4 study testing Ferinject and Normal Saline Flush in people with Coronary Artery Disease, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this prospective open-label randomized tral, 100 patients with elective off-pump coronary artery bypass (OPCAB) or minimal invasive direct coronary bypass (MIDCAB) surgery were enrolled. Read more about this study

Who is it for?
Ages 19 to 85 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Ferinject and Normal Saline Flush
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteSouth Korea
Study dates
10 Feb 2019to 31 Dec 2022
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 19 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients aged 19 years or older
  • undergoing elective OPCAB or MIDCAB surgery with multi-vessel coronary artery disease.

Who cannot join

  • Patients who underwent iron correction treatment (oral, injection, blood transfusion) within 2 months prior to surgery
  • Patients taking anticoagulants before surgery
  • Patients taking and administering drugs that can cause bone marrow suppression, such as anticancer drugs, before surgery
  • Patients with chronic liver disease and chronic kidney disease undergoing dialysis
  • Patients scheduled for coronary artery bypass graft for emergency surgery
  • Patients with a history of hypersensitivity reactions and side effects to iron drugs
Show all 11Show fewer
  • Minor (under 20 years old)
  • Definition of iron deficiency anemia (if all criteria a to c in the following items are satisfied)
  • Ferritin<300mcg/L
  • Transferrin saturation<25%
  • Hb<12.0g/dL for women or Hb<13.0g/dL for men

Trial locations and contacts

1 site in 1 country.

Young-Nam Youn contact

82-10-9930-4522

ysgs@yuhs.ac

South Korea1 site, 1 recruiting

  • Yonsei University Health System, Severance Hospital

    Seoul

    Young-Nam Youn, 82-10-9930-4522, ysgs@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

In this prospective open-label randomized tral, 100 patients with elective off-pump coronary artery bypass (OPCAB) or minimal invasive direct coronary bypass (MIDCAB) surgery were enrolled. Before surgery, if a patient had iron deficiency anemia, the patient was randomized to receive Ferinject®(Ferric carboxymaltose, n=50) or placebo (normal saline, n=50), respectively. A single dose should not exceed 1000mg of iron per day or 20mg per kg body weight. In addition, the administration of 1000mg of iron should not exceed once a week. Administration to patients with hemodialysis-dependent chronic kidney disease is once daily, and the maximum dose should not exceed 200 mg (4 ml) of iron. Patients weighing less than 35 kg should not exceed 500 mg total iron dose. It uses intravenous infusion and can be administered up to 1,000mg (20ml) as the maximum iron once. For intravenous infusion, this drug is diluted with 0.9% sterile physiological saline solution.

Read the detailed description
  • Perioperative blood loss and iatrogenic hemodilution lead to postoperative anemia which correlates with infections, and poor physical function, mobility and recovery with subsequent increases in the length of hospital stay and mortality. Preoperative anemia management reduce intraoperative blood loss such as normothermia, antifibrinolytics and cell salvage are key strategies to ameliorate postoperative anemia.
  • Patient screening method Off-pump coronary artery bypass (OPCAB) under median-sternotomy, or minimal invasive direct coronary bypass (MIDCAB) undertaken under median-sternotomy Among them, the selection/exclusion criteria are checked and the subjects of the study are screened. * Inclusion/ exclusion criteria **Inclusion:
  • Patients with Preoperative iron deficiency anemia Among Patients scheduled for cardiopulmonary coronary artery bypass graft under median sternotomy in cardiovascular surgery **Exclusion: - a) Patients who underwent iron correction treatment (oral, injection, blood transfusion) within 2 months prior to surgery b) Patients taking anticoagulants before surgery c) Patients taking and administering drugs that can cause bone marrow suppression, such as anticancer drugs, before surgery d) Patients with chronic liver disease and chronic kidney disease undergoing dialysis e) Patients scheduled for coronary artery bypass graft for emergency surgery f) Patients with a history of hypersensitivity reactions and side effects to iron drugs g) Minor (under 20 years old) 3) Definition of iron deficiency anemia (if all criteria a to c in the following items are satisfied)
  1. Ferritin<300mcg/L
  2. Transferrin saturation<25%
  3. Hb<12.0g/dL for women or Hb<13.0g/dL for men * The primary goal of this study was the effect of intravenous administration of ferric carboxymaltose on postoperative hemoglobin levels in patients with preoperative iron deficiency anemia among patients requiring cardiopulmonary coronary artery bypass grafting due to coronary artery disease. It is to analyze the effect compared to the control.
Being tested
Ferinject, Normal Saline Flush
Keywords
Bleeding, Blood transfusion, Coronary artery bypass surgery, Hemostasis, Iron therapy
Medical subject headings
Coronary Artery Disease, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FerinjectDrug

    Also called Colloidal solution of the iron complex ferric carboxymaltose

    Ferric carboxymaltose injection

  • Normal Saline FlushDrug

    Also called placebo comparator

    placebo

Study groups in NCT04898569
Study groupRoleWhat they receive
Ferinject®ExperimentalNot described
Receives: Drug: Ferinject
Normal salinePlacebo comparatorNot described
Receives: Drug: Normal Saline Flush

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total mediastinal blood loss and transfusion counts

    For cost-effectiveness analysis of ferric carboxymaltose in preoperative iron treatment

    Measured: At admission periods for Off-Pump Coronary Artery Bypass or Minimally Invasive Direct Coronary Artery Bypass surgery (Mean 8~9 days)

Secondary outcomes (6)

  1. blood loss in the operative day

    Measured: 24 hours later after surgery

  2. amount of blood products transfused both intraoperatively and postoperatively

    Measured: 24 hours later after surgery

  3. rate of surgical revision for bleeding

    Measured: intraoperative

  4. total length of intensive care unit (ICU) stay

    Measured: mean 3-4 days

  5. rate of postoperative morbidity

    Measured: Participants will be followed during 1 years from operation

  6. rate of postoperative mortality

    Measured: Participants will be followed during 1 years from operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2021
  2. Study start10 Feb 2019
  3. Primary completion1 Oct 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

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
Model description
In cardiac surgery, patients were randomized to receive Ferinject or placebo (n=50), respectively. The selected agent was intravenous infusion in general ward, preoperatively.
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04898569
Sponsor's protocol ID
4-2018-0371
Status last verified
May 2021
First submitted
19 May 2021
Last updated
24 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Banerjee S, McCormack S. Intravenous Iron Preparations for Patients Undergoing Elective Surgery: A Review of Clinical Effectiveness, Cost-Effectiveness, and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2019 Mar 27. Available from http://www.ncbi.nlm.nih.gov/books/NBK545893/

    PubMed 31487129

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ferinject and Normal Saline Flush in people with Coronary Artery Disease, 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 2 inclusion and 11 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 24 May 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 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.

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 Young-Nam Youn (82-10-9930-4522, ysgs@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total mediastinal blood loss and transfusion counts (time frame: At admission periods for Off-Pump Coronary Artery Bypass or Minimally Invasive Direct Coronary Artery Bypass surgery (Mean 8~9 days)). 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 NCT04898569, 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 24 May 2021.

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