Itagaki Yuki, Hayakawa Mineji, Takahashi Yuki, Kushimoto Shigeki, Sakamoto Yuichiro, Seki Yoshinobu, Okamoto Kohji
Emergency and Critical Care Center, Hokkaido University Hospital, Sapporo, Japan.
Shock. 2025 May 1;63(5):695-705. doi: 10.1097/SHK.0000000000002534. Epub 2024 Dec 19.
Background: Death in the early phase of trauma is primarily attributable to uncontrolled bleeding exacerbated by trauma-induced coagulopathy (TIC). A comprehensive synthesis of the available evidence on interventions for TIC is needed. Methods: We conducted a systematic review and meta-analysis of blood component products and tranexamic acid administrations for severe trauma patients with TIC. We included randomized and nonrandomized controlled trials. We included studies with patients who required transfusion with any coagulopathy associated with trauma and a detailed definition. The intervention was administration of blood component products and tranexamic acid. The primary outcome of the study was all-cause mortality and transfusion quantity. Results: Four randomized controlled trials and seven observational studies were included in the qualitative synthesis. In this study, fibrinogen concentrate (FC), prothrombin coagulation cofactor (PCC), and Combination administrations of FC and PCC (FC + PCC) administration did not significantly reduce mortality rates. FC, PCC, and FC + PCC administrations significantly reduced RBC transfusions after admission. In addition, PCC administration reduced FFP transfusions during hospital admission. The incidence of thrombotic events was not significantly higher in the FC + PCC, PCC, and rFVIIa groups. Although statistically nonsignificant, multiple organ failure was lower in the FC and FC + PCC groups. Conclusions: FC and PCC administrations did not significantly reduce mortality. However, FC, PCC, and FC + PCC reduced transfusion rates and complications in patients with coagulopathy-associated trauma. However, the definition of TIC is quite heterogeneous. Thus, the definition of TIC should be defined universally. Furthermore, because of the lack of high certainty of evidence, further well-constructed trials are warranted to investigate the efficacy of blood component products, specifically FC and PCC supplementation for TIC.
创伤早期死亡主要归因于创伤性凝血病（TIC）加剧的失控性出血。需要对TIC干预措施的现有证据进行全面综合分析。方法：我们对TIC严重创伤患者的血液成分制品和氨甲环酸给药进行了系统评价和荟萃分析。我们纳入了随机和非随机对照试验。我们纳入了有任何与创伤相关凝血病且有详细定义、需要输血的患者的研究。干预措施为血液成分制品和氨甲环酸给药。该研究的主要结局是全因死亡率和输血量。结果：定性综合分析纳入了4项随机对照试验和7项观察性研究。在本研究中，纤维蛋白原浓缩物（FC）、凝血酶原凝血辅因子（PCC）以及FC与PCC联合给药（FC + PCC）并未显著降低死亡率。FC、PCC和FC + PCC给药显著降低了入院后的红细胞输注量。此外，PCC给药降低了住院期间的新鲜冰冻血浆输注量。FC + PCC、PCC和重组活化凝血因子VII（rFVIIa）组血栓形成事件的发生率并未显著更高。尽管无统计学意义，但FC组和FC + PCC组的多器官功能衰竭发生率较低。结论：FC和PCC给药并未显著降低死亡率。然而，FC、PCC和FC + PCC降低了凝血病相关创伤患者的输血率和并发症。然而，TIC的定义相当不一致。因此，TIC的定义应统一界定。此外，由于证据的确定性不足，有必要进行进一步精心设计的试验来研究血液成分制品的疗效，特别是FC和PCC补充治疗TIC的疗效。
