病原体减少的冷沉淀与冷沉淀 AHF 降低手术输血（TOP-CLOT）的试验：一项单中心、前瞻性、整群随机试验的研究方案。

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

机构信息

Department of Pathology, Weill Cornell Medicine, 1300 York Avenue, New York, NY, USA.

Department of Anesthesiology, Weill Cornell Medicine, 1300 York Avenue, New York, NY, USA.

出版信息

Trials. 2024 Sep 27;25(1):625. doi: 10.1186/s13063-024-08398-x.

DOI:10.1186/s13063-024-08398-x

PMID:39334317

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11430273/

Abstract

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.

摘要

背景

心脏手术中的术中出血会增加发病率和死亡率。术前和围手术期纤维蛋白原水平较低，这是一种关键的凝血因子，与出血的严重程度和血液成分的输注增加有关。由于解冻后的储存寿命较短，冷冻储存的冷沉淀抗血友病因子（cryo AHF）在止血复苏期间补充纤维蛋白原的能力会延迟 45-60 分钟。可以在室温下解冻并保存长达 5 天的病原体减少的冷沉淀纤维蛋白原复合物（INTERCEPT Fibrinogen Complex，IFC），使其可以立即用于出血的患者。本试验将研究在出血性心脏手术患者中，与 cryo AHF 相比，使用 IFC 更早纠正获得性低纤维蛋白原血症是否可以减少围手术期输注的同种异体血液制品（红细胞、血浆和血小板）的总数。

方法

这是一项单中心、前瞻性、集群随机试验，采用适应性设计。通过旋转血栓弹性描记法（ROTEM）评估获得性低纤维蛋白原血症，将 cryo AHF/IFC 输注的阈值定义为出血患者的 FIBTEM A10≤10mm。IFC/cryo AHF 将按 1 个月的块进行随机化。如果患者有合适的手术程序，并且至少输注了一剂 cryo AHF/IFC 产品（约 2g 纤维蛋白原），则将其纳入本研究。电子健康记录的数据，包括血库和实验室信息系统，将从医疗系统的数据仓库中前瞻性收集。