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

NCT04898569 | Unknown Phase 4 DMC

• 1 other identifier: 4-2018-0371
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Artery Disease

Keywords

Bleeding; Blood transfusion; Coronary artery bypass surgery; Hemostasis; Iron therapy

Outcome Measures

Primary Outcomes (1)

• Total mediastinal blood loss and transfusion counts

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

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

Secondary Outcomes (6)

• blood loss in the operative day

  24 hours later after surgery

• amount of blood products transfused both intraoperatively and postoperatively

  24 hours later after surgery

• rate of surgical revision for bleeding

  intraoperative

• total length of intensive care unit (ICU) stay

  mean 3-4 days

• rate of postoperative morbidity

  Participants will be followed during 1 years from operation

Study Arms (2)

Ferinject®

EXPERIMENTAL

Drug: Ferinject

Normal saline

PLACEBO COMPARATOR

Drug: Normal Saline Flush

Interventions

Ferinject DRUG

Ferric carboxymaltose injection

Also known as: Colloidal solution of the iron complex ferric carboxymaltose

Ferinject®

Normal Saline Flush DRUG

placebo

Also known as: placebo comparator

Normal saline

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

• 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/

  PMID: 31487129 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Hemorrhage

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Young-Nam Youn

  Division of Cardiovascular Surgery, Severance Cardiovascular Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Nam Youn

CONTACT

82-10-9930-4522; ysgs@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients were offered the allocated treatment for ferric carboxymaltose or not, using the block randomization system. The selected agent was infused to patients after randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In cardiac surgery, patients were randomized to receive Ferinject or placebo (n=50), respectively. The selected agent was intravenous infusion in general ward, preoperatively.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: February 10, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 31, 2022
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)