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Four-factor prothrombin complex concentrate to reduce allogenic blood product transfusion in patients with major trauma, the PROCOAG trial: study protocol for a randomized multicenter double-blind superiority study
Trials ( IF 2.0 ) Pub Date : 2021-09-16 , DOI: 10.1186/s13063-021-05524-x
Pierre Bouzat 1 , Jean-Luc Bosson 2 , Jean-Stéphane David 3 , Bruno Riou 4 , Jacques Duranteau 5 , Jean-François Payen 1 ,
Affiliation  

Optimal management of severe trauma patients with active hemorrhage relies on adequate initial resuscitation. Early administration of coagulation factors improves post-traumatic coagulation disorders, and four-factor prothrombin complex concentrate (PCC) might be useful in this context. Our main hypothesis is that four-factor PCC in addition to a massive transfusion protocol decreases blood product consumption at day 1 in severe trauma patients with major bleeding. This is a prospective, randomized, multicenter, double-blind, parallel, controlled superiority trial. Eligible patients are trauma patients with major bleeding admitted to a French level-I trauma center. Patients randomized in the treatment arm receive 1 mL/kg (25 IU/ml of Factor IX/Kg) four-factor PCC within 1-h post-admission while patients randomized in the controlled group receive 1 mL/kg of saline solution 0.9% as a placebo. Treatments are given as soon as possible using syringe pumps (120 mL/h). The primary endpoint is the amount of blood products transfused in the first 24 h post-admission (including red blood cells, frozen fresh plasma, and platelets). The secondary endpoints are the amount of each blood product transfused in the first 24 h, time to achieve prothrombin time ratio < 1.5, time to hemostasis, number of thrombo-embolic events at 28 days, mortality at 24 h and 28 days, number of intensive care unit-free days, number of ventilator-free days, number of hospital-free days within the first 28 days, hospitalization status at day 28, Glasgow outcome scale extended for patients with brain lesions on initial cerebral imaging, and cost of each strategy at days 8 and 28. Inclusions have started in December 2017 and are expected to be complete by June 2021. If PCC reduces total blood consumption at day 1 after severe trauma, this therapy, in adjunction to a classic massive transfusion protocol, may be used empirically on admission in patients at risk of massive transfusion to enhance coagulation. Moreover, this treatment may decrease blood product-related complications and may improve clinical outcomes after post-traumatic hemorrhage. ClinicalTrials.gov NCT03218722 . Registered on July 14, 2017

中文翻译:

四因子凝血酶原复合物浓缩物可减少严重创伤患者的同种异体血制品输注,PROCOAG 试验:随机多中心双盲优势研究的研究方案

对伴有活动性出血的严重创伤患者的最佳管理依赖于充分的初始复苏。早期给予凝血因子可改善创伤后凝血障碍,四因子凝血酶原复合物浓缩物 (PCC) 可能在这种情况下有用。我们的主要假设是,除了大量输血方案外,四因素 PCC 可减少严重创伤伴大出血患者第 1 天的血液制品消耗。这是一项前瞻性、随机、多中心、双盲、平行、对照优势试验。符合条件的患者是法国一级创伤中心收治的大出血创伤患者。随机分配到治疗组的患者在入院后 1 小时内接受 1 mL/kg(25 IU/ml 因子 IX/Kg)四因子 PCC,而随机分配到对照组的患者接受 1 mL/kg 0.9% 的盐水溶液作为安慰剂。使用注射泵 (120 mL/h) 尽快进行治疗。主要终点是入院后第一个 24 小时内输注的血液制品量(包括红细胞、新鲜冷冻血浆和血小板)。次要终点是前 24 小时输血的每种血液制品的量、达到凝血酶原时间比率 < 1.5 的时间、止血时间、28 天血栓栓塞事件的数量、24 小时和 28 天的死亡率、重症监护室无天数、无呼吸机天数、前 28 天内无住院天数、在第 28 天的住院状态,格拉斯哥结果量表在初始脑成像时扩大了脑损伤患者,在第 8 天和第 28 天扩大了每种策略的成本。纳入从 2017 年 12 月开始,预计到 2021 年 6 月完成。如果 PCC 降低严重创伤后第 1 天的总血液消耗量,这种疗法与经典的大量输血方案相结合,可在有大量输血风险的患者入院时凭经验使用以增强凝血。此外,这种治疗可能会减少与血液制品相关的并发症,并可能改善创伤后出血后的临床结果。ClinicalTrials.gov NCT03218722。2017 年 7 月 14 日注册 纳入已于 2017 年 12 月开始,预计将在 2021 年 6 月完成。如果 PCC 在严重创伤后的第 1 天减少总血液消耗,则该疗法与经典的大量输血方案相结合,可在患者入院时凭经验使用大量输血以增强凝血的风险。此外,这种治疗可能会减少与血液制品相关的并发症,并可能改善创伤后出血后的临床结果。ClinicalTrials.gov NCT03218722。2017 年 7 月 14 日注册 纳入已于 2017 年 12 月开始,预计将在 2021 年 6 月完成。如果 PCC 在严重创伤后的第 1 天减少总血液消耗,则该疗法与经典的大量输血方案相结合,可在患者入院时凭经验使用大量输血以增强凝血的风险。此外,这种治疗可能会减少与血液制品相关的并发症,并可能改善创伤后出血后的临床结果。ClinicalTrials.gov NCT03218722。2017 年 7 月 14 日注册 这种治疗可能会减少与血液制品相关的并发症,并可能改善创伤后出血后的临床结果。ClinicalTrials.gov NCT03218722。2017 年 7 月 14 日注册 这种治疗可能会减少与血液制品相关的并发症,并可能改善创伤后出血后的临床结果。ClinicalTrials.gov NCT03218722。2017 年 7 月 14 日注册
更新日期:2021-09-16
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