Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study protocol for a single center, prospective, cluster randomized trial.

BACKGROUND: Intraoperative hemorrhage in cardiac surgery increases risk of morbidity and mortality. Low pre-operative and perioperative levels of fibrinogen, a key clotting factor, are associated with severity of hemorrhage and increased transfusion of blood components. The ability to supplement fibrinogen during hemorrhagic resuscitation is delayed 45-60 min because cryoprecipitated antihemophilic factor (cryo AHF) is stored frozen, due to a short post-thaw shelf life. Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) can be kept thawed, at room temperature, for up to 5 days, making it possible to be immediately available for hemorrhaging patients. This trial will investigate if earlier correction of acquired hypofibrinogenemia with IFC in hemorrhaging cardiac surgery patients reduces the total number of perioperatively transfused allogeneic blood products (red blood cells, plasma, and platelets) as compared to cryo AHF. METHODS: This is a single center, prospective, cluster randomized trial with an adaptive design. Acquired hypofibrinogenemia will be assessed by rotational thromboelastometry (ROTEM) and the threshold for cryo AHF/IFC transfusion defined as FIBTEM A10 ≤ 10 mm in bleeding patients. IFC/cryo AHF will be randomized by 1-month blocks. Cardiac surgery patients will be enrolled in the study if they have an eligible procedure and at least one dose of a cryo AHF/IFC product (approximately 2 g fibrinogen) is transfused. Data from the electronic health record, including the blood bank and lab information systems, will be prospectively collected from the health system's data warehouse. DISCUSSION: This trial aims to provide evidence of the clinical efficacy of utilizing readily available thawed IFC during acute bleeding in the cardiac surgery setting compared to traditional cryo AHF. TRIAL REGISTRATION: ClinicalTrials.gov NCT05711524. Feb 3, 2023.

What every intensivist should know about..Patient safety huddles in the ICU.

Patient safety huddles are brief, multidisciplinary conversations that focus on a specific topic or event. Huddles have been shown to improve communication among healthcare providers in a variety of settings, including the intensive care unit (ICU). This paper presents key features of patient safety huddles and describes the ways in which huddle techniques may be particularly relevant to the practice of critical care.

Temperature Outcomes without heater cooler units in adult patients supported with extracorporeal membrane oxygenation: A retrospective cohort study.

INTRODUCTION: Heater-cooler units (HCUs) are frequently incorporated into extracorporeal membrane oxygenation (ECMO) circuits to help maintain patient normothermia. However, these devices may be associated with increased cost and infection risk. This study describes our institution's experience managing adult ECMO patients without the routine use of in-circuit HCUs. METHODS: We performed a retrospective analysis of adult patients treated with veno-venous (VV) or veno-arterial (VA) ECMO at our institution. The primary outcomes were rates of HCU use and the relative duration of the ECMO treatment course in which patients maintained normothermia (36-37.5°C), with and without HCUs. Secondary outcomes of mortality and ECMO-related complications were planned across HCU and non-HCU groups; exploratory analyses were performed across a 75% "ECMO time in normothermia" threshold. RESULTS: Among a cohort of 71 patients, zero (0%) were managed with in-circuit HCUs. A majority of ECMO patient-hours were spent in the normothermic range. Median and mean percentages of ECMO normothermia time were 75% (IQR 49%-81%) and 62% (SD ± 27%). Twenty-nine patients (40%) met the threshold of 75% ECMO normothermia time, as used to evaluate secondary outcomes. At this threshold, mortality risk was significantly higher among the non-normothermic cohort; other ECMO-related complications did not vary significantly. CONCLUSIONS: In the absence of HCU use, the majority of ECMO patient-hours were spent in normothermia. However, only a minority of patients achieved normothermia for at least 75% of their ECMO course. In-circuit HCUs may be required to maintain high percentages of normothermic time in adult EMCO patients.