Status:
UNKNOWN
Patient Blood Management in Cardiac Surgery in Turkiye
Lead Sponsor:
ERAS Turkey Association
Conditions:
Coronary Artery Disease
Iron Deficiency Anemia
Eligibility:
All Genders
18-80 years
Brief Summary
* Rationale and background: Surgical patients' transfusions have changed from replacing surgically lost blood with allogenic blood transfusions to implementing strategies that reduce transfusion requi...
Detailed Description
Patient blood management (PBM) is defined as "the timely application of evidence-based medical and surgical concepts designed to maintain hemoglobin concentration, optimize haemostasis and minimize bl...
Eligibility Criteria
Inclusion
- Signed patient informed consent
- Male or female patient 18-80 years old
- Patients scheduled for elective first time coronary artery bypass grafting (CABG)
- Antiplatelet treatment will be discontinued in patients on antiplatelet therapy and will be operated after wash-out time as recommended in the guidelines. If the patient needs to be operated before wash-out period completed, then the patient will be excluded from the study.
- Patients with confirmed iron deficiency anemia (IDA), defined as Hb 100-130 g/L, and serum ferritin \< 100 ng/ml or TSAT \< 20%.
- Patients with iron deficiency anemia in the "PBM active group" will be taken into surgery 3 weeks after the treatment for study group.
Exclusion
- Patients that undergo emergency surgical procedure
- Patients with non-iron deficiency anaemia (thalassemia, sickle cell anemia and etc)
- Patients with renal anemia (Hb \< 130 g/L and CCL \< 50 mL/min, irrespective of iron parameters) or any diagnosis that require EPO
- Patients with Hb \< 100 g/L
- Patients with known anaphylactic/hypersensitivity reactions to parenteral iron products
- Patients with iron overload or disturbances in utilization of iron (e.g., haemochromatosis, hemosiderosis)
- Patients with ≥3 times increase in aspartate aminotransferase or alanine aminotransferase as per reference range
- Patients with excessive blood loss requiring massive transfusion (≥ 10 more red blood cell units)
- Patients with known myelodysplastic syndromes
- Patients with chronic kidney disease with an estimated CCL \< 50 mL/min or with end-stage renal disease requiring scheduled dialysis
- Patients with known urinary tract infections with urea-splitting bacteria
- Any patient judged to lack the ability to give informed consent or perform the trial assessments (e.g., due to dementia)
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential),
- Known or suspected non-compliance, drug or alcohol abuse
- Patients who will be re-operated after being included in study
- Participation in another study with investigational drug within the 30 days preceding and during the present study.
- Patients receiving ≥10 units of RBCs within 24h from start of surgery.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT06084871
Start Date
June 1 2023
End Date
June 1 2025
Last Update
October 16 2023
Active Locations (1)
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1
Ankara University School of Medicine Heart Center
Ankara, Turkey (Türkiye), 06340