Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery,JAMA

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Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery
JAMA ( IF 63.1 ) Pub Date : 2019-11-26 , DOI: 10.1001/jama.2019.17312
Jeannie Callum _{1,

2,

3} , Michael E Farkouh _{4,

5} , Damon C Scales _{6,

7} , Nancy M Heddle _{8,

9} , Mark Crowther ₉ , Vivek Rao _{4,

10,

11} , Hans-Peter Hucke ₁₂ , Jo Carroll _{4,

11,

13} , Deep Grewal _{4,

11,

13} , Sukhpal Brar _{14,

15} , Jean Bussières ₁₆ , Hilary Grocott ₁₇ , Christopher Harle ₁₈ , Katerina Pavenski ₁₉ , Antoine Rochon ₂₀ , Tarit Saha ₂₁ , Lois Shepherd ₂₂ , Summer Syed ₂₃ , Diem Tran ₂₄ , Daniel Wong ₂₅ , Michelle Zeller ₂₆ , Keyvan Karkouti _{4,

6,

13,

27} ,

Affiliation

Department of Laboratory Medicine and Molecular Diagnostics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Laboratory Medicine Program, University Health Network, Toronto, Ontario, Canada.
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.
Heart and Stroke Richard Lewar Centre, University of Toronto, Toronto, Ontario, Canada.
Interdepartmental Division of Critical Care, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
Sunnybrook Research Institute, Department of Critical Care Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
University Health Network, Division of Cardiovascular Surgery, Toronto General Hospital, Toronto, Ontario, Canada.
University of Toronto, Toronto, Ontario, Canada.
Department of Biostatistics, ERGOMED CDS GmbH, Cologne, Germany.
Department of Anesthesia and Pain Management, Sinai Health System, Women's College Hospital, University Health Network, Toronto, Ontario, Canada.
Department of Anesthesiology, Pharmacology and Therapeutics; University of British Columbia, Vancouver, Canada.
Royal Columbian Hospital, Vancouver, British Columbia, Canada.
Anesthesiology Department, Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval, Québec City, Québec, Canada.
Departments of Anesthesiology, Perioperative and Pain Medicine, and Surgery, University of Manitoba, Winnipeg, Canada.
Department of Anesthesia and Perioperative Medicine, Western University, London, Ontario, Canada.
St Michael's Hospital, Division of Transfusion Medicine, Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.
Department of Anesthesiology, Montréal Heart Institute, Université de Montréal, Montréal, Québec, Canada.
Department of Anesthesiology and Perioperative Medicine; Kingston General Hospital, Queen's University, Kingston, Ontario, Canada.
Department of Pathology and Molecular Medicine, Kingston Health Science Center, Queen's University, Kingston, Ontario, Canada.
Department of Anesthesiology; Hamilton Health Sciences Corporation, McMaster University, Hamilton, Ontario, Canada.
University of Ottawa Heart Institute, Division of Cardiac Anesthesiology and Critical Care, Department of Anesthesia and Pain Medicine, University of Ottawa School of Epidemiology and Public Health, Ottawa, Ontario, Canada.
Cardiac Surgery, Royal Columbian Hospital, University of British Columbia, Vancouver, Canada.
McMaster Centre for Transfusion Research, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
Department of Anesthesia and Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.

Importance Excessive bleeding is a common complication of cardiac surgery. An important cause of bleeding is acquired hypofibrinogenemia (fibrinogen level <1.5-2.0 g/L), for which guidelines recommend fibrinogen replacement with cryoprecipitate or fibrinogen concentrate. The 2 products have important differences, but comparative clinical data are lacking. Objective To determine if fibrinogen concentrate is noninferior to cryoprecipitate for treatment of bleeding related to hypofibrinogenemia after cardiac surgery. Design, Setting, and Participants Randomized clinical trial at 11 Canadian hospitals enrolling adult patients experiencing clinically significant bleeding and hypofibrinogenemia after cardiac surgery (from February 10, 2017, to November 1, 2018). Final 28-day follow-up visit was completed on November 28, 2018. Interventions Fibrinogen concentrate (4 g; n = 415) or cryoprecipitate (10 units; n = 412) for each ordered dose within 24 hours after cardiopulmonary bypass. Main Outcomes and Measures Primary outcome was blood components (red blood cells, platelets, plasma) administered during 24 hours post bypass. A 2-sample, 1-sided test for the ratio of the mean number of units was conducted to evaluate noninferiority (threshold for noninferiority ratio, <1.2). Results Of 827 randomized patients, 735 (372 fibrinogen concentrate, 363 cryoprecipitate) were treated and included in the primary analysis (median age, 64 [interquartile range, 53-72] years; 30% women; 72% underwent complex operations; 95% moderate to severe bleeding; and pretreatment fibrinogen level, 1.6 [interquartile range, 1.3-1.9] g/L). The trial met the a priori stopping criterion for noninferiority at the interim analysis after 827 of planned 1200 patients were randomized. Mean 24-hour postbypass allogeneic transfusions were 16.3 (95% CI, 14.9 to 17.8) units in the fibrinogen concentrate group and 17.0 (95% CI, 15.6 to 18.6) units in the cryoprecipitate group (ratio, 0.96 [1-sided 97.5% CI, -∞ to 1.09; P < .001 for noninferiority] [2-sided 95% CI, 0.84 to 1.09; P = .50 for superiority]). Thromboembolic events occurred in 26 patients (7.0%) in the fibrinogen concentrate group and 35 patients (9.6%) in the cryoprecipitate group. Conclusions and Relevance In patients undergoing cardiac surgery who develop clinically significant bleeding and hypofibrinogenemia after cardiopulmonary bypass, fibrinogen concentrate is noninferior to cryoprecipitate with regard to number of blood components transfused in a 24-hour period post bypass. Use of fibrinogen concentrate may be considered for management of bleeding in patients with acquired hypofibrinogenemia in cardiac surgery. Trial Registration ClinicalTrials.gov Identifier: NCT03037424.

中文翻译：

纤维蛋白原浓缩物与冷沉淀对心脏手术后血液成分输血的影响

重要性过度出血是心脏手术的常见并发症。出血的一个重要原因是获得性低纤维蛋白原血症（纤维蛋白原水平<1.5-2.0 g/L），指南建议用冷沉淀或纤维蛋白原浓缩物替代纤维蛋白原。两种产品有重要差异，但缺乏比较临床数据。目的确定纤维蛋白原浓缩物在心脏手术后低纤维蛋白原血症相关出血的治疗中是否不劣于冷沉淀。设计、设置和参与者在 11 家加拿大医院进行的随机临床试验招募了心脏手术后出现临床显着出血和低纤维蛋白原血症的成年患者（从 2017 年 2 月 10 日到 2018 年 11 月 1 日）。最后的 28 天随访于 2018 年 11 月 28 日完成。干预体外循环后 24 小时内每次订购剂量的纤维蛋白原浓缩物（4 g；n = 415）或冷沉淀物（10 单位；n = 412）。主要结果和措施主要结果是在旁路术后 24 小时内给予的血液成分（红细胞、血小板、血浆）。对平均单位数的比率进行 2 样本、单侧检验以评估非劣效性（非劣效性比率的阈值，<1.2）。结果在 827 名随机分组的患者中，735 名（372 名浓缩纤维蛋白原，363 名冷沉淀）接受了治疗并被纳入初步分析（中位年龄，64 [四分位距，53-72] 岁；30% 为女性；72% 接受了复杂手术；95%中度至重度出血；和预处理纤维蛋白原水平，1.6 [四分位距，1.3-1.9] g/L）。在计划的 1200 名患者中的 827 名被随机分组后，该试验在中期分析中满足了非劣效性的先验停止标准。纤维蛋白原浓缩组平均 24 小时异基因输血为 16.3（95% CI，14.9 至 17.8）单位，冷沉淀组为 17.0（95% CI，15.6 至 18.6）单位（比率，0.96 [单侧 97.5% CI，-∞ 至 1.09；P < .001 表示非劣效性] [两侧 95% CI，0.84 至 1.09；P = .50 表示优效性]）。纤维蛋白原浓缩物组 26 名患者 (7.0%) 和冷沉淀组 35 名患者 (9.6%) 发生血栓栓塞事件。结论和相关性在接受心脏手术的患者中，体外循环后出现临床显着出血和低纤维蛋白原血症，在旁路术后 24 小时内输注的血液成分数量方面，浓缩纤维蛋白原不劣于冷沉淀。可以考虑使用纤维蛋白原浓缩物来治疗心脏手术中获得性低纤维蛋白原血症患者的出血。试验注册 ClinicalTrials.gov 标识符：NCT03037424。

更新日期：2019-11-26

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