Early and balanced replacement of blood products appears to be the key factor in improving outcomes of major bleeding patients including acute trauma, cardiac, obstetric and transplant surgery patients. Definitive clinical guidance regarding the optimal ratio of blood products, including those containing fibrinogen, is still lacking. Therefore, we tested the hypothesis that increasing the fibrinogen content to erythrocyte suspension ratio improves the mortality and functional outcomes of patients undergoing surgeries with expected major bleeding.

The Approximate Dose-Equivalent of Fibrinogen-to-Erythrocyte Suspension (ADEFES) ratio is a multicentre, prospective, observational, cohort study of patients undergoing major surgical procedures with expected major perioperative bleeding (ie, requiring packed red blood cells (PRBC)>4U/24 hours). For 5U of cryoprecipitate and 1.5 U of fresh frozen plasma (FFP), the approximate dose-equivalent for fibrinogen is considered as 1 gram of fibrinogen. Association of the ADEFES ratio at 24 hours will be assessed on the primary objective, which will consist of the composite of 30-day all-cause mortality, 30-day bleeding-specific mortality and the ‘highly-dependent scores’ of Katz index of independence in activities of daily living.

The study protocol was approved by the Ethics Committee of Ankara Bilkent City Hospital (approval no. E2-23-4265, dated 07 June 2023; Chair: Prof. Dr. F.E. Canpolat) and by the institutional review boards of all participating centres. The study will be conducted in accordance with the principles of the Declaration of Helsinki and the Strengthening the Reporting of Observational Studies in Epidemiology guidelines, as well as in compliance with national regulations on data protection and Good Clinical Practice standards. Written informed consent will be obtained from all participants prior to inclusion in the study.

The results of this study will be disseminated through peer-reviewed scientific journals, presentations at national and international conferences, and communication with relevant stakeholders including clinical practitioners and healthcare institutions. If applicable, study outcomes will also be shared via institutional newsletters and digital platforms to reach a broader audience in the medical community.

NCT06021184.

Diabetic foot ulcer (DFU) is a major complication of poorly managed diabetes mellitus. Home care of individuals with chronic wounds is often supported by family members. The study aims to determine the burden of caregivers of DFU patients and the factors influencing this burden.

A descriptive-correlational research.

The study sample consisted of caregivers of patients who applied to the Diabetic Foot Council between December 2022 and November 2023.

The study included 101 caregivers who were primarily responsible for the care of the DFU patient, had been caring for the patient for at least 2 months, provided unpaid care and agreed to participate in the study.

Data were collected using the Descriptive Characteristics Form and Zarit Caregiver Burden Scale.

The mean age of the caregivers was 45.34±12.62, and the mean age of the patients was 59.57±9.18. The care burden of caregivers was 46.47±11.39. The highest levels of care burden were observed in the economic and dependency subscales. When the relationship between the independent variables of the model and the dependent variable was examined, it was found that providing support to move the patient [β=0.97; p=0.001] and the need for training in patient care [β=0.51; p=0.012] were independent factors that increased the burden of the caregiver, while the patient’s ability to follow his/her own medication [β=–0.46; p=0.039] was the independent factor that decreased the burden of the caregiver.

Based on these findings, further research is required to assess the effectiveness of professional healthcare services, self-care interventions and support strategies aimed at alleviating caregiver burden and enhancing care quality.