PDF(Pubmed)
Abstract：
COVID-19 disease is associated with a hyperinflammatory, pro-thrombotic state and a high mortality. Our primary objective was to assess the change in inflammatory and thrombotic markers associated with PEX, and secondary objectives were to assess the effects of PEX on progression of respiratory failure and incidence of acute thrombotic events. We conducted a prospective, phase II, non-blinded randomised control trial of plasma exchange compared to standard of care in critically ill adults with severe COVID-19 associated respiratory failure, requiring supplemental oxygen or ventilatory support and elevated thrombo-inflammatory markers (LDH, CRP, ferritin, and D-Dimer). Patients randomised to receive PEX were treated with a daily single volume plasma exchange for a minimum of five days. Twenty-two patients were randomised of who 11 received PEX. Demographic and clinical characteristics were similar between groups at presentation. PEX was associated with a significant reduction in pro-thrombotic markers FVIII, VWF and VWF Ag: ADAMTS 13 ratio (p < 0.001). There were no differences in the reduction of inflammatory markers, severity of respiratory failure (p = 0.7), thrombotic events (p = 0.67), or mortality (p > 0.99) at 28 days. PEX successfully reduced pro-thrombotic markers, although was not associated with reduction in inflammatory markers, respiratory failure, or thrombotic events.Trial registration: (NCT04623255); first posted on 10/11/2020.
摘要：
COVID-19疾病与炎症过度有关，血栓前状态和高死亡率。我们的主要目的是评估与PEX相关的炎症和血栓标志物的变化，次要目标是评估PEX对呼吸衰竭进展和急性血栓事件发生率的影响.我们进行了一个前瞻性的，第二阶段,在患有严重COVID-19相关呼吸衰竭的危重成人中进行血浆置换与标准治疗相比的非盲随机对照试验，需要补充氧气或通气支持和升高的血栓炎症标志物(LDH，CRP,铁蛋白,和D-二聚体）。随机接受PEX的患者每天进行单体积血浆置换治疗至少五天。22名患者被随机分配，其中11名患者接受PEX。两组之间的人口统计学和临床特征相似。PEX与血栓前标志物FVIII的显著降低相关，VWF和VWFAg:ADAMTS13比率(p<0.001)。炎症标志物的减少没有差异，呼吸衰竭的严重程度（p=0.7），血栓事件（p=0.67），或死亡率（p>0.99）在28天。PEX成功地降低了血栓前标志物,尽管与炎症标志物的减少无关，呼吸衰竭,或血栓事件。试用登记：（NCT04623255）；首次发布于2020年10月11日。
