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Patient Blood Management in Cardiac Surgery in Turkiye

NCT06084871 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 368

Last updated 2023-10-16

No results posted yet for this study

Summary

* 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.

Conditions

Sponsors & Collaborators

  • ERAS Turkey Association

    lead OTHER

Principal Investigators

  • Onat Bermede, MD · Ankara University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-12-31
Completion
2025-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06084871 on ClinicalTrials.gov