Improving blood management in heart surgery in Turkey

Patient Blood Management in Cardiac Surgery in Turkiye

This study is testing if giving intravenous iron before heart surgery can help patients with anemia have better recovery and need fewer blood transfusions.

Quick facts

• Study type: Observational
• Enrollment: 368 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: ERAS Turkey Association (other)
• Locations: 1 site (Ankara)
• Trial ID: NCT06084871 on ClinicalTrials.gov

What this trial studies

This study evaluates the implementation of Patient Blood Management (PBM) strategies in patients undergoing elective coronary artery bypass grafting (CABG) in Turkey. PBM aims to maintain hemoglobin levels, optimize hemostasis, and minimize blood loss to enhance postoperative outcomes and reduce the need for blood transfusions. The study will focus on patients with iron deficiency anemia, assessing the efficacy of preoperative intravenous iron treatment. By analyzing transfusion practices and patient outcomes, the study seeks to provide evidence for improved blood management protocols in cardiac surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 scheduled for elective first-time CABG with confirmed iron deficiency anemia.

Not a fit: Patients undergoing emergency surgeries or those with non-iron deficiency anemia will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to reduced blood transfusions and improved recovery outcomes for patients undergoing heart surgery.

How similar studies have performed: Previous studies have shown success with multimodal PBM approaches, indicating potential for positive outcomes in this context.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Ankara

• Ankara University School of Medicine Heart Center — Ankara, Turkey (RECRUITING)

Study contacts

• Principal investigator: Onat Bermede, MD — Ankara University
• Study coordinator: Onat Bermede, MD

Conditions: Coronary Artery Disease, Iron Deficiency Anemia, Patient blood management, CABG, intravenous iron