Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898569
Status:
UNKNOWN
Last Update Posted:
2021-05-24
First Post:
2021-05-19
Brief Title:
Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response and Transfusion in Patients With Iron Deficiency Anemia After Off-Pump Coronary Artery Bypass Grafting
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response and Transfusion in Patients With Iron Deficiency Anemia After Off-Pump Coronary Artery Bypass Grafting
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 FerinjectFerric carboxymaltose n50 or placebo normal saline n50 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 1000mg 20ml as the maximum iron once For intravenous infusion this drug is diluted with 09 sterile physiological saline solution
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 selectionexclusion 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 Ferritin300mcgL
2 Transferrin saturation25
3 Hb120gdL for women or Hb130gdL 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
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 selectionexclusion 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 Ferritin300mcgL
2 Transferrin saturation25
3 Hb120gdL for women or Hb130gdL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None