Status:
UNKNOWN
Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response and Transfusion in Patients With Iron Deficiency Anemia After Off-Pump Coronary Artery Bypass Grafting
Lead Sponsor:
Yonsei University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
19-85 years
Phase:
PHASE4
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 sur...
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...
Eligibility Criteria
Inclusion
- patients aged 19 years or older
- undergoing elective OPCAB or MIDCAB surgery with multi-vessel coronary artery disease.
Exclusion
- 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
Key Trial Info
Start Date :
February 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04898569
Start Date
February 10 2019
End Date
December 31 2022
Last Update
May 24 2021
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea