NCT06084871: PaBMiCS

Patient Blood Management in Cardiac Surgery in Turkiye

Status unknown Last updated 16 October 2023

What this trial tests

trial in Coronary Artery Disease in 368 participants. Status unknown.

Timeline

1 June 2023

Primary endpoint
31 December 2024

1 June 2025

Quick facts

Lead sponsor	ERAS Turkey Association
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	368
Start date	1 June 2023
Primary completion	31 December 2024
Estimated completion	1 June 2025
Sites	1 location across Turkey (Türkiye)

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →
• Iron Deficiency Anemia — all drugs for Iron Deficiency Anemia →

Sponsor

ERAS Turkey Association

Who can join

Adults 18 to 80, any sex, with Coronary Artery Disease or Iron Deficiency Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

* Rationale and background: Surgical patients' transfusions have changed from replacing surgically lost blood with allogenic blood transfusions to implementing strategies that reduce transfusion requirements. Patient Blood Management (PBM) is designed to maintain hemoglobin concentration, optimize hemostasis, and minimize blood loss to improve patient outcomes. There is mounting evidence that multimodal PBM programs can improve postoperative outcomes and reduce perioperative blood transfusions and costs. The TULIP study in Turkey showed higher uses of blood transfusions in major surgical patients, including coronary artery surgeries in Turkey. The current studies also support the preoperative use of intravenous iron and/or vitamin B12/folic acid in major surgical patients. So, we aim to evaluate the efficacy of implantation of PBM in CABG surgeries in Turkey.
* Research question and objectives: Is it possible to decrease the amount of perioperative blood and blood products transfusions by implementing PBM in patients who underwent CABG surgeries? The primary objective of the study is to demonstrate the reduction in perioperative RBC units transfused, when PBM is implemented in cardiac surgery in Turkey. The secondary objectives are to evaluate the concurrent reduction of FFP, platelet and total blood products used as compared to a control group, length of hospital and ICU stay following the surgery.
* Study design: A prospective, multicenter, non-interventional study with a historical/retrospective control group.
* Population: Patients who are operated on for coronary artery bypass grafting.
* Variables: Demographic (age, sex), clinical (body mass index, comorbidities, ASA score, P-POSSUM score, Charlson Comorbidity Index), operative (type and duration of operations), laboratory (hemoglobin, platelet count, coagulation profile), laboratory for anemia (transferrin saturation, ferritin, creatinine clearance), preoperative treatment, transfusion data, and outcome (morbidity, mortality, lengths of hospital stay).
* Exposures: Preoperative IV iron treatment of anemia.
* Data sources: Medical data of the patients are obtained after entering a prespecified database (e-CRF) for the study subjects. For the control group, the medical data of the patients will be obtained retrospectively from the database of the TULIP study.
* Study size: Study group: A total of 368 patients from five different centers across Turkey. Control group: at least 368 patients from the same centers attending the TULIP study. Finally, 736 patients will be included for the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.